Kornimate/medical-research-clean huggingface dataset:
tidal model's effects on emotion regulation and recovery

Conditions: Depression

Summary: the aim of this study is to investigate the effectiveness of tidal model-based emotion regulation interventions on recovery in individuals diagnosed with depression and nursing diagnosis of impaired mood regulation. the research was designed as a randomized controlled trial. the main hypothesis; after nursing interventions for emotion regulation based on the tidal model, there is a significant difference between the recovery, difficulty in emotion regulation, depression levels and nursing outcome criteria of individuals in the intervention and control groups.

the research carried out with patients followed in psychiatry outpatient clinics. as a result of the g-power analysis, the sample consisted of 23 interventions and 23 control groups. in the study, while the control group received only routine treatment, in the intervention group, tidal model-based nursing interventions were applied in addition to the routine treatment. pre-tests administered before individuals were randomly assigned to the intervention and control groups. randomization was created using the website randomizer.org. after this randomization was created, it was hidden from the physician who made the diagnosis of depression and from the researcher who conducted the interviews (allocation concealment). after the pre-tests were completed, the researcher (consulting faculty member) who knew the random assignment order was reached and the individuals were randomly assigned to the control or intervention group. tidal model-based nursing interventions were structured as 8 sessions in total. each individual in the intervention group participated in a session for a total of 8 weeks, one session per week. in the eighth session, post-tests were applied to the individuals in the intervention group. individuals in the control group were asked to come back 8 weeks after the first interviews and post-tests were applied. all interviews were conducted face to face. recovery assessment scale (ras), difficulties in emotion regulation scale (ders), and nursing outcomes criteria (noc) were used.

Eligibility criteria:
inclusion criteria: * diagnosis of moderate depression according to diagnostic and statistical manual of mental disorders (dsm)-v criteria * having a nursing diagnosis of impaired mood regulation * psychiatrist prescribing serotonin reuptake inhibitor (ssri) * man or women aged 25-55 * being followed by the psychiatry outpatient clinic * able to provide written informed consent exclusion criteria: * presence of an additional mental illness * diagnosis of severe depression according to dsm-v criteria * presence of suicidal attempts or thoughts * presence of another physical illness that affects cognition * have received any kind of therapy in the last six months * voluntary involvement in another study at the same time * inability to read and write

Keywords: emotional regulation psychiatric nursing tidal model recovery
placental transfusion project for preterm infants

Conditions: Intraventricular Hemorrhage; Sepsis; Necrotizing Enterocolitis

Summary: the american college of obstetrics and gynecology, american academy of pediatrics and the world health organization have recently published recommendations related to placental transfusions in preterm infants. this project will review outcomes of preterm infants following a quality improvement implementation process in several delivery centers in indiana. centers involved in this project are also part of the indiana vermont oxford network (irb#1003-84). data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the vermont oxford network collection. this project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the acog recommendations.

centers involved in this project are also part of the indiana vermont oxford network. data is recorded for that network and the investigators site will be reviewing that data every 3 months from infants who have completed the vermont oxford network collection. this project will specifically look at the incidence of intraventricular hemorrhage, necrotizing entercolitis, periventricular leukomalacia, sepsis and death following the implementation of the acog recommendations.

Eligibility criteria:
inclusion criteria: * preterm infants born at participating hospital who are less than 30 weeks gestation or less than 1500 grams and/or preterm infants 30 weeks to less than 34 weeks gestation exclusion criteria: * none
efficacy and safety of biphasic insulin aspart 30 in combination with metformin in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to investigate the efficacy on blood glucose control in type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 6 months * insulin naive. short term insulin treatment (7 days or less within the last 6 months) is allowed * previous treatment with oral antidiabetic drugs for at least 4 months * judged by the investigator to be eligible for an insulin analogue plus oral antidiabetic drug treatment regimen * bmi below 40 kg/m2 * hba1c between 7-12% * able and willing to perform self-plasma glucose monitoring exclusion criteria: * the receipt of any other investigational drug within 4 weeks before screening * a history of drug or alcohol abuse within the last 12 months * severe, uncontrolled hypertension * known or suspected allergy to trial products or related products
improvement of self management for oncologic patients with pain

Conditions: Pain; Cancer

Summary: this study will test the scion (self care improvement through oncology nursing)-pain program, a multi-modular structured intervention to improve self management in oncologic patients with pain compared to care as usual (standard pain treatment and standard care). the study will determine if the self management skills of the patients continue to be used when the intervention stops, e.g. after discharge from hospital. it is hypothesized that patients who receive the multi-modular structured intervention will have less patient-related barriers to the management of cancer pain.

according to modified "precede model of health behavior" from green, patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. therefore, we conduct a cluster randomized clinical trial (c-rct) that will test the effectiveness of scion-pain program against care as usual on self pain management of the patient and average pain level. as allocation to intervention or control is performed on the level of wards, randomization is stratified by ward profile (e.g. gynaecological, haematological, urological). wards were included if they agreed to participate and had more than 10% patients with a diagnosis of cancer in 2006. wards with a pediatric profile were excluded. adult oncology patients with persistent pain will be recruited by the nurses of the participating wards under the guidance of a research nurse. patients are included in the trial if they meet the inclusion criteria and sign informed consent. they will receive the intervention that the respective ward was allocated to. the scion-pain program as a multi modular structured nursing intervention (see arm description) will be conducted by specially trained ward nurses in cooperation with the research nurse. the intervention will include components of knowledge, skills training, and coaching (particularly against patient-related barriers to pain medication) to improve cancer pain management. patients in intervention group will receive follow-up telephone counseling within 2 to 3 days after discharge. the self management skills of the patients will be observed up to 28 days post discharge. both quantitative and qualitative analyses will be conducted to evaluate patient outcomes.

Eligibility criteria:
inclusion criteria: * adult oncology patients * able to read, write, and understand german * agree to participate and give informed consent * have an average pain intensity score of \> 3.0 on a 0 to 10 nrs * pain persists for more than 3 days * scheduled for another visit to the clinic exclusion criteria: * documented actual alcohol or drug abuse * surgery within the last 3 days * disorientated to date, place and situation * have a ecog performance score of 4

Keywords: self care symptom management pain cancer nurse coaching patient education
computer based training in cognitive behavioral therapy web-based

Conditions: Substance Abuse

Summary: the investigators are conducting a randomized clinical trial of our new web-based version of the cbt4cbt program to evaluate its effectiveness relative to standard outpatient counseling at satu. the computer-based training program (cbt4cbt) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

one hundred eighty drug-using individuals seeking treatment at the substance abuse treatment unit (satu) of the connecticut mental health center will be randomized to (1) standard outpatient counseling at satu (typically consisting of weekly group counseling), (2) individual clinician delivered cbt, or (3) web-based cbt4cbt. treatments will be delivered over a 12-week period with a six-month follow-up after termination of the study treatments. the primary outcome measures will be reduction in substance use (frequency of drug use by time, confirmed by urine toxicology screens). secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based cbt4cbt retains key characteristics of traditional clinician-administered cbt (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Eligibility criteria:
inclusion criteria: * are 18 years of age or older. * are applying for outpatient, non-agonist substance abuse treatment at satu. * meet current dsm-iv criteria for cocaine, marijuana,opioid,or amphetamine dependence. * are sufficiently stable for 12 weeks of outpatient treatment. * can commit to 12 weeks of treatment and are willing to be randomized to treatment * are willing to provide locator information for follow-up. * are fluent in english and have a 6th grader or higher reading level exclusion criteria: * have an untreated bipolar or schizophrenic disorder. * who have a current legal case pending such that incarceration during 12-week protocol is likely. * are physically dependent on alcohol, opioids or benzodiazepines

Keywords: cognitive behavior therapy computer assisted instruction drug abuse therapy educational resource design and development
use of aeeg as predictor of long-term motor outcome in neonates with congenital heart disease

Conditions: Congenital Heart Disease

Summary: this study aims to examine performance on a neurological screening test, the dubowitz, and sleep wake cycles on amplitude integrated electroencephalogram (aeeg) in neonates with congenital heart disease (chd) as a way to potentially predict longterm motor outcome. it will compare the results of these studies to neonates without chd.

neonates with congenital heart disease are at increased risk of adverse long term neurodevelopmental outcomes, including lower mean intelligent quotients (iqs). however, it is difficult to predict with neonates are most likely to be affected and a cost effective method is needed. aeeg has been used in neonates with hypoxic-ischemic encephalopathy and abnormal sleep wake cycles have been proposed to predict poorer long term outcomes. we thus hypothesize that abnormal sleep wake cycles in neonates with congenital heart disease will correlate with poorer outcomes. in our study, we will examine the relationship between performance on a neurodevelopmental screening tool, the dubowitz neonatal neurological screening tool, and the sleep wake cycles on aeeg both before and after cardiac repair to try and predict which neonates are at increased risk of adverse long term outcomes. we will also compare the findings of the aeeg and performance on the neurodevelopmental tool to the data gathered from neonates without cardiac disease.

Eligibility criteria:
inclusion criteria: * newborn with cardiac anomaly requiring surgical intervention or a newborn that is in nicu for at least 24 hours for monitoring * if newborn has congenital cardiac anomaly, cardiac repair must be performed at mount sinai hospital * if newborn has congenital cardiac anomaly, he/she must be managed pre-operatively for at least 24 hours at mount sinai hospital * if newborn has congenital cardiac anomaly, he/she must be managed post-operatively at mount sinai hospital for at least 72 hours exclusion criteria: * newborns with previously known anomalies other than cardiac * chromosomal abnormalities other than 22q, that might have long-term neurodevelopmental implications * diagnosis of hypoxic-ischemic encephalopathy * metabolic disorder * other genetic disorders

Keywords: congenital heart disease neurodevelopmental outcome aeeg sleep wake cycles
open-label study comparing iberdomide, daratumumab and dexamethasone (iberdd) versus daratumumab, bortezomib, and dexamethasone (dvd) in participants with relapsed or refractory multiple myeloma (rrmm)

Conditions: Multiple Myeloma

Summary: this is a multicenter, two-stage, randomized, controlled, open-label, phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (iberdd) versus daratumumab, bortezomib, and dexamethasone (dvd) in participants with relapsed or refractory multiple myeloma (rrmm).

this is a multicenter, two-stage, randomized, controlled, open-label, phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (iberdd) versus daratumumab, bortezomib, and dexamethasone (dvd) in participants with relapsed or refractory multiple myeloma (rrmm). approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (treatment arms a1, a2, or a3), or to the dvd comparator arm (treatment arm b). in stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms: * approximately 332 subjects will be randomized to receive treatment arm a (iberdd) * approximately 332 subjects will be randomized to receive treatment arm b (dvd) participants in both treatment arms will continue to receive treatment until confirmed progressive disease (pd), unacceptable toxicity or withdrawal of consent. to ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (pfs), participants who permanently discontinue study treatment for any reason, other than confirmed pd or withdrawal of consent, will continue to be followed for disease assessment. the study will be conducted in compliance with international council for harmonisation (ich) and good clinical practices (gcps).

Eligibility criteria:
inclusion criteria * documented diagnosis of multiple myeloma (mm) and measurable disease. * received 1 to 2 prior lines of anti-myeloma therapy. * must have documented disease progression during or after their last anti-myeloma regimen. * eastern cooperative oncology group (ecog) performance status score of 0, 1 or 2. exclusion criteria * any condition that confounds the ability to interpret data from the study. * has plasma cell leukemia, waldenstrom's macroglobulinemia or poems syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis. * known central nervous system involvement with mm. * prior therapy with iberdomide. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: iberdomide cc-220 daratumumab darzalex faspro bortezomib velcade dexamethasone mm multiple myeloma rrmm celmod cereblon modulators
the reus-tarragona birth cohort study of early development and ageing.

Conditions: Intrauterine Development

Summary: the recent fall in birth and death rates has led to demographic changes such as low fertility and high life expectancy . the who reports the median age of the european population to be the highest in the world and predicts that the proportion of over-60s in will increase from 14% in 2010 to 25% in 2050. there is wide variability in the quality of health and well-being in the ageing population. longevity with a good quality of life is a consequence of the combination of an individual's genes, nutrition, environment, lifestyle and medical interventions. there is increasing evidence that research into healthy ageing needs to start with early life data to capture all traits and exposures experienced by an individual throughout life. epigenetic imprinting occurs both in utero and during early postnatal development. maternal environmental exposures, including nutritional status, may have a permanent effect on the developing foetus by influencing epigenetic profiles and leading to life-long genome adaptation. numerous reports show that restricted intra-uterine growth due to poor maternal nutrition during pregnancy increases risk in the offspring of developing mental disorders, metabolic syndrome, cardiovascular disease or stroke in later life. to understand the basic mechanisms and interactions through which the ageing phenotype develops, systems involved in key processes of early development must be considered as well as those crucial to health in older persons. the reus and tarragona birth cohort is a longitudinal study. in the first phase, blood is collected from pregnant women at \<12, 15, 24-27 and 34 gestational weeks (gw) and at labor and from the cord. detailed lifestyle, habits and supplement use data are collected at 20 and 32 gestational weeks and on nutritional habits at \<12gw and at birth. placental vascular function is assessed at 20 and 32 gw by analysis of doppler waveforms of the uterine arteries. data on pregnancy evolution and outcome are also recorded. the first phase investigates the association between gene-environment (nutrient and lifestyle habits) interactions and fetal growth and pregnancy outcome. the second phase of the study follows up the children at 7.5 years of age. growth, exercise and nutritional habits as well as environment and cognitive development are assessed. the aims are to investigate the association between gene-environment interactions associated with healthy development from early pregnancy until 7.5 years of age.


Eligibility criteria:
inclusion criteria: * \<12 weeks pregnant at first prenatal check up exclusion criteria: * illnesses / interventions affecting nutritional status, major recent surgery in the previous 6 months, multiple pregnancies
study to analyze the clinical and cost impact of complete and incomplete rotavirus (rv) vaccination

Conditions: Infections, Rotavirus

Summary: this study aims to estimate the clinical and cost impact of rv vaccinations (both rotateq® and rotarix®) among children aged less than 5 years using insurance claims data from commercial plans and medicaid low-income population. the impact of incomplete and complete rv vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months, 8 months and onwards ) and calendar time of rv vaccination (e.g., 2006 onward).

insurance claims data from the marketscan commercial claims and encounters database {marketscan commercial (2000-2011\[q2\])} and the marketscan multi-state medicaid database {marketscan medicaid (2002-2010)} will be analyzed separately; no merging of the databases will occur. the claims data extracts are fully de-identified and compliant with the health insurance portability and accountability act of 1996 (u.s.) (hipaa). for children who received at least 1 rv vaccine dose within the advisory committee on immunization practices (acip)-specified vaccination window of 6 weeks to 8 months old, their observation time will be divided into three rv-vaccinated cohorts: any rv vaccination before 8 months (i.e., during the vaccination window between 6 weeks and 8 months old); complete rv vaccination (i.e., after 8 months old); and incomplete rv vaccination (i.e., after 8 months old). for children who did not receive any rv vaccine dose within the vaccination window, their observation time will be divided into four control cohorts: historical (i.e., before rv vaccines were available) unvaccinated on/before 8 months old; contemporary (i.e., after rv vaccines were available) unvaccinated on/before 8 months old; historical unvaccinated after 8 months old; and contemporary unvaccinated after 8 months old.

Eligibility criteria:
inclusion criteria: * continuously enrolled from birth. (note: due to the absence of birth dates in insurance claims data, this inclusion criterion will be met if a child's year of first enrollment and year of birth are the same. if so, then the date of first enrollment will be used as proxy for date of birth.) * received both medical and pharmacy benefits. exclusion criteria: * enrolled in capitation-based health plans. * for marketscan commercial, residence in states with universal vaccination programs that include the rv vaccine or where rv vaccine inclusion cannot be ascertained (i.e., alaska, idaho, massachusetts, maine, north dakota, new hampshire, new mexico, oregon, rhode island, vermont, washington, wisconsin, and wyoming). * lost to follow-up or had rv prior to 6 weeks of age.

Keywords: cost children rotavirus rotavirus vaccination clinical