Kornimate/medical-research-clean huggingface dataset:
effect of drying before plastic wrapping on thermal losses in very preterm infants at birth

Conditions: Temperature Regulation; Disorder, Fetus or Newborn

Summary: this is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. the aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants.

background: hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge. a list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (nicu) admission suggesting that further measures are needed. while drying is recommended for the thermal management of infants with gestational age \>32 weeks, this procedure is not indicated for very preterm infants who should be put in a plastic wrap immediately at birth without drying. however, such indication is based on studies comparing wrapping without drying vs. drying without wrapping, while the potential advantages of combining these interventions were not explored. we hypothesized that drying before wrapping could prevent heat loss immediately after birth and reduce hypothermia at nicu admission in very preterm infants. objective: the aim of this study will be to compare two modes of thermal management (plastic wrapping with or without drying) for preventing heat loss at birth in very preterm infants. methods: this is a multicenter, unblinded, randomized controlled trial comparing drying vs. not drying before plastic wrapping for the thermoregulation of very preterm infants at birth. after obtaining parental consent, all infants with estimated birth weight \ 37.5°c) at nicu admission; temperature at 1 hour after nicu admission; proportion of intraventricular hemorrhage; proportion of respiratory distress syndrome; proportion of late onset sepsis; proportion of bronchopulmonary dysplasia; mortality before hospital discharge.

Eligibility criteria:
inclusion criteria: * estimated birth weight \<1500 g and/or gestational age ≤30+6 weeks (and) * inborn (and) * parental consent; written informed consent will be obtained by a member of the neonatal team involved in the study from a parent or guardian at the maternal admission to the obstetric department. exclusion criteria: * major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...); * outborn; * parental refusal to participate in the study.

Keywords: newborn prematurity temperature delivery
optimizing screening for cervical cancer among women living with hiv in the dominican republic

Conditions: Malignant Female Reproductive System Neoplasm

Summary: this study compares different screening approaches to detect abnormal cell growth on the cervix that could be an early sign of cervical cancer. the lesions are caused by an infection of human papillomavirus, also called hpv. using new methods to detect hpv may help doctors find ways to improve cervical cancer screening for women living with human immunodeficiency virus (hiv) in the dominican republic and in other countries.

outline: participants participate in three annual interviews and clinical exams that last approximately 2 hours. study participants provide blood, urine, and swab samples from the cervix, anus, and vagina and receive a pelvic exam. any positive results are followed up in the study clinic.

Eligibility criteria:
inclusion criteria: * women ages 25 - 49 years old will be eligible to participate in the study * women living with hiv who have an intact cervix * intent to reside in the santo domingo area * ability to attend routine study visits at idcp for at least 24 months during the study. if women report that they anticipate relocating in the subsequent 24 months or anticipate difficulty attending study visits they will not be eligible * ability to understand the study timeline and procedures and the willingness to complete the informed consent process are also inclusion criteria exclusion criteria: * women with a prior diagnosis of cervical cancer or a history of treatment for cervical precancerous lesions (cin2+) will be excluded * women with significant physical, mental, or social conditions that would limit participation with study procedures will not be eligible for the study * women who are pregnant or report an intent to become pregnant in the subsequent 3 months will not be eligible for the study * women who have no history of vaginal sexual exposure will not be eligible for the study
advanced patient monitoring and a.i. supported outcomes assessment in lung cancer using internet of things technologies (a.i. - apalitt)

Conditions: Non-small-cell Lung Cancer

Summary: the use of advanced technological tools able to exploit patient-centered "real world data", represents an innovative and fascinating challenge for the most modern personalized medicine paradigms. monitoring oncological patients during multimodal cancer therapies may represent a significant step towards a comprehensive and reliable quality of life assessment, prevention of toxicity before its clinical onset and treatment outcomes prediction. the big data approach, being able to collect, manage and interpret large volumes of health data, eventually supported by artificial intelligence (a.i.) is therefore fundamental in this setting and may be translated in the next future in tangible advantages for the patients. primary aim of the project is to assess patients experience of using portable monitoring systems during multimodal oncological therapies and follow up period, through the use of a dedicated app and wearable technology (i.e. monitoring bracelet), as electronic health record data harvesting devices. more specifically, the patients report experience measure of man/women affected by locally advanced non-small-cell lung cancer undergoing chemo(radio)therapy followed either by surgery or immunotehrapy (e.g. describing toxicity, instrumental activities of daily living and stress/coping levels) will be analyzed. the machine learning assisted analysis of these data will allow to identify patients profile that may be used as risk categories to optimize assistance and follow up practices. this is an observational study with device, co-financed, monocentric study with a foreseen study duration of 36 months.


Eligibility criteria:
inclusion criteria: * aged \< 75 * clinically able to use portable technologies * able to understand and sign informed consent exclusion criteria: * major psychiatric disorder * ecog\>2 performance status * not able to use portable technologies
measuring the effect of remote monitoring of treatment adherence on the risk of re-admission of ambulatory schizophrenic patients

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. this study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse.

schizophrenia is a chronic debilitating mental disorder, characterised by a relapsing remitting course. although anti-psychotics can prevent relapse, its effect on schizophrenia outcome remains very limited, mainly due to very poor adherence to medications by the patients. this study aims to find, whether the add-on of remote monitoring of medication compliance via tele-medicine, to routine out-patient clinic care, can improve patients adherence and reduce the risk of relapse. the study is an uni center, open, prospective, randomised and controlled.

Eligibility criteria:
inclusion criteria: * dsm 4 diagnosis of schizophrenia or schizoaffective * able to give written informed consent * have a telephone line exclusion criteria: * are not discharged to a place with routine medication monitoring * are not discharged under forced ambulatory treatment order * are not homeless * are not admitted due to drug intoxication or withdrawal. * are not admitted due to severe self harm.

Keywords: schizophrenia schizoaffective disorder disease management treatment rehabilitation pharmacotherapy
genomic search for childhood obesity genes-a pilot study

Conditions: Obesity

Summary: the purpose of this study is to screen a pediatric population (ages 2-8) for genes associated with childhood obesity.

the incidence of childhood obesity has been growing at an epidemic rate for the past several years, in part due to the lack of understanding of mechanisms at a molecular level. this study will screen a healthy general pediatric population age 2 to 8 for potential genes associated with childhood obesity using whole genomic gene arrays. patients with bmi values equal to or greater than the 85th percentile will be compared to patients with a bmi below or equal to the 15th percentile. the insig2 gene will be specifically studied because of its identification in several populations of obese subjects. the differences in gene expression of the 2 groups will then be used to identify new genes for investigation in childhood obesity.

Eligibility criteria:
inclusion criteria: * ages 2-8, predominately caucasian to minimize population stratification exclusion criteria: * chronic diseases (diabetes, cancer, etc) and known syndromes

Keywords: obesity
transcranial direct current stimulation as home treatment in depression

Conditions: Depression

Summary: in this one-armed study the feasibility and effectiveness of a home treatment with transcranial direct currect stimulation in depression will be investigated.

in this one-armed study at least 10 patients with depression will be included who will get treatment with transcranial direct currect stimulation at home. one visit in the hospital before and one visit after the treatment are necessary. the correct application of the device by the patients will be ensured by video counseling and monitoring. treatment will last six weeks with 2 ma applied every working day for 20min with prefrontal montage. aim of the study is the evaluation of the feasibility of this home treatment (usability of the device, compliance of patients, usability of the video contacts), the effectiveness (clinical ratings) and the tolerability of this treatment.

Eligibility criteria:
inclusion criteria: * depressive episode according to icd-10 * moderate depression according to clinical impression or hamilton depression rating scale * gender: all sexes * age: 18-70 years * stable medication if possible * no or stable treatment of depression * residence in germany and mother language german * written informed consent exclusion criteria: * contraindications for transcranial direct current stimulation * neurological conditions * participiation in another study * pregnancy and lactation period
evaluation of biomarkers for postoperative complications in non-cardiac surgery patients

Conditions: Perioperative/Postoperative Complications; Outcome

Summary: aim of this study is to evaluate whether the periopertive course is able to predict postoperative complications. several approaches will be choosed to optimize perioperative risk stratification predicting postoperative complications in patients undergoing elective non-cardiac surgery.

the aim of this secondary analysis of the superadd study is to use the perioperative data from the prospective superadd study ("substitution of perioperative albumin deficiency disorders") (eudra-ct 2016-001313-24; clinical trials nct03167645; doi: 10.1097) to identify risk factors for the occurrence of postoperative complications, based on the clavien-dindo classification in the nine domains of the postoperative morbidity survey. multivariate analyses, decision trees, time series analysis and machine learning methods will be applied to distinguish risk factors for postoperative complikations and mortality in a high-risk group (see publication of the statistical analysis plan and its enhancement). patients participating in the superadd study (nct03167656) and who had at least two perioperative high sensitive troponin t (hstnt) values in order to detect myocardial injury were included in this secondary analysis as hstnt is associated with major adverse cardiovascular events (mace), myocardial injury after noncardiac surgery and mortality. the secondary analysis uses data obtained at the pre-anaesthesia visit like asa, preoperative comorbidities measured by the pospom, cci, intraoperative parameters like vitals, medication, estimated blood loss and postoperative data obtained from pacu records and discharge letter. primary endpoint are postoperative complications assessed with the cavien-dindo classification \> 2.

Eligibility criteria:
inclusion criteria: * written informed consense * age \> 18 years * asa score 3 or 4 * elective non-cardiac high risk surgery exclusion criteria: * emergency surgery * need for dialysis * liver cirrhosis child c * intolerance of albumin * participation in other amg (medicines law) study * pregnancy or breastfeeding * patients with attendants concerning medical matters * asa v patients * patients with bmi \> 35 kg/m2

Keywords: perioperative outcome clavien-dindo classification hstnt mins
low dose st john's wort for depression

Conditions: Major Depression

Summary: this observational study observes the routine use of low-dose st john's wort herbal mother tincture in patients with major depression. it measures intensity of depression at the beginning of st johns wort and after 6 weeks and evaluates tolerability and compliance.

herbal medicine is widely used, and high-quality evidence shows their efficacy and tolerability for specific disorders. most of the studies, however, is conducted with standardized, relatively high dosed dry extract preparations, while other preparations such as tinctures are widely used as well. the aim of this observational study ist to document real-live use of the use of a low-dose herbal medicine preparation (a mother tincture) of st john's wort (hypericum perforatum), to compare depression intensity at the beginning and after 6 weeks of therapy using the hamilton depression scale 17, and to evaluate tolerability and compliance. finally, the results will be compared with results of randomized controlled trials examining high dosed dry extract preparations of st john's wort for major depression.

Eligibility criteria:
inclusion criteria: * diagnosis of mild or moderate depression according to icd-10 or dsm-iv * new start of ceres st john's wort mother tincture exclusion criteria: - at the same time as st john's wort mother tincture started, other antidepressive therapy
the control trial: cryotherapy vs. compression neuropathy trial

Conditions: CIPN - Chemotherapy-Induced Peripheral Neuropathy

Summary: the primary objective of this study is to select the best intervention from cold therapy, compression therapy and placebo at reducing neuropathic pain as measured by the change in the neurotoxicity (ntx) component of the functional assessment of cancer therapy (fact) - taxane questionnaire, following 12 weeks of neoadjuvant/adjuvant chemotherapy with paclitaxel or docetaxel among breast cancer patients.

chemotherapy-induced peripheral neuropathy (cipn) is a frequent side effect resulting from the administration of cytotoxic chemotherapeutic agents. the incidence of cipn can vary on the type of agent used, the frequency with which it is given, and the cumulative dose. unfortunately, for some patients, symptoms may persist even after discontinuation of the drug due to irreversible nerve damage. as of now, there are no established agents for cipn prevention. this is a randomized, placebo-controlled clinical selection trial of interventions for cipn in patients treated with docetaxel every 3 weeks or paclitaxel on a weekly schedule. patients will be randomly assigned to receive either frozen gloves and socks, compression gloves and socks, or "loose" gloves and socks (placebo arm) during chemotherapy infusion to study the best intervention at reducing neuropathic pain.

Eligibility criteria:
inclusion criteria: * age greater or equal to 18 years. * history of stage i-iii breast cancer * patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks * signed informed consent * eastern cooperative oncology group (ecog) performance status ≤2 (karnofsky ≥60%,) exclusion criteria: * prior treatment with taxane or platinum based chemotherapy * known history of neuropathy * raynaud's phenomenon * peripheral arterial ischemia * cold intolerance * current use of duloxetine which may mitigate chemotherapy-induced peripheral neuropathy (cipn)

Keywords: neuropathy cipn cryotherapy compression therapy
interdisciplinary weight loss therapy associate with the use of interactive digital technology

Conditions: Obesity

Summary: obesity is a complex disease associate to metabolic alterations, which may lead to cardiometabolic risk in women with obesity. the use of interactive digital technology as adjuvante tool to the clinical practices in weight loss therapy emerges as an innovative strategy. however, it was note fully investigated if this kind of approach can contribute to improve inflammatory state and metabolic alterations in obese population.

this study consists in a 12-week clinical interdisciplinary weight loss therapy, with endocrinologist, nutritionist, psychologist and exercise physiologist to evaluate the effects of clinical interdisciplinary therapy associated to use the eletronic means on inflammatory biomarkers and metabolic alterations in women with obesity. the present study was composed by a sample of obese women (20 to 45 years old), recruited through advertisements in the media (newspapers, magazines, radio, television and social media - twitter®, facebook® and instagram®). the volunteers lived in the city of são paulo or nearby, so they could attend monthly the university on the days of the clinical, nutritional, psychological and exercise evaluations, counseling, educational sessions and motivational strategies supporting adherence. to complete the education behaviors program the volunteers follow weekly the instructions found in the platform #12semanas®. all participants met the inclusion criteria for the obesity profile according to the world health organization (who), presenting body mass index (bmi) values above 30 kg/m². patients with any pathology that could compromise the results of the study (heart disease, musculoskeletal deformities, diseases related to the immune system, genetic, metabolic or endocrine diseases, identified by the physician) were not included in the study. anthropometric measures, body composition by bio-impedance and bood samples were collected to serum analysis.

Eligibility criteria:
inclusion criteria: * obesity diagnosis; * body mass index (bmi) values above 30 kg/m² * adult * aged 20-45 years exclusion criteria: * presence of heart diseases * musculoskeletal deformities * diseases related to the immune system

Keywords: obesity comorbidities inflammation digital technology metabolic alterations
bioss lim c vs 2nd generation des in non-lm bifurcations

Conditions: Coronary Artery Disease

Summary: coronary bifurcations are encountered in about 15 - 20% of percutaneous coronary interventions (pci). they are considered technically challenging and associated with worse clinical outcomes than non-bifurcation lesions. percutaneous coronary intervention (pci) to the target bifurcation lesion. randomization (by means envelope randomization) to investigational device: group 1 for bioss lim c implantation vs group 2 for any des implantation.

single stent implantation in the main vessel-main branch across a side branch is the default strategy (provisional t-stenting, pts) in all patients enrolled. bifurcation lesions are assessed according to medina classification using an index of 1 for stenosis greater than 50% and 0 for no stenosis (visual estimation). there is no restriction regarding lesion length in patient selection. if required, additional stent can be implanted (alex plus in the bioss lim c group). a stent in a side branch (alex plus in the bioss lim c group) should be implanted only if there is proximal residual stenosis greater than 70% after balloon dilatation and/or significant flow impairment after main vessel - main branch stenting and/or a flow limiting dissection. the implantation protocol for bifurcation is as follows: 1. wiring of both branches; 2. main vessel predilatation and/or side branch predilatation according to the operator's decision; 3. stent implantation (inflation for at least 20 s); 4. proximal optimization technique (pot) 5. side branch postdilatation/side branch stent implantation if necessary 6. final kissing balloon inflation at operator's discretion. 7. second proximal optimization technique (re-pot)

Eligibility criteria:
inclusion criteria: 1. subject at least 18 years of age. 2. subject able to verbally confirm understandings of risks, benefits of receiving pci for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure. 3. target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm. 4. target lesion(s) amenable for pci with balloon angioplasty of the side branch. exclusion criteria: 1. non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment). 2. subjects who refuse to give informed consent. 3. subjects with lvef\<30% 4. subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy 5. distal lm stenosis

Keywords: dedicated bifurcation stent non-lm bifurcation sirolimus-eluting stent
eating behaviors in shift workers

Conditions: Shift Work Type Circadian Rhythm Sleep Disorder; Eating Behavior

Summary: this study will compare eating behaviors and measures of hunger and fullness between day and night workers in order to better understand why night workers are at increased risk for obesity and related diseases.


Eligibility criteria:
inclusion criteria: * work \~ 8-hour shifts during day or night on 3 or more consecutive days of the week * bmi 19-35 kg/m\^2 * age 20-55 years of age * metabolically healthy * weight stable over previous 3 months * lives in new york city area exclusion criteria: * pregnant or less than 1 year postpartum at time of study * smoking * history of drug or alcohol abuse * rotating shift work * habitual sleep duration of more than 6 hour per night * obstructive sleep apnea * transmeridian travel * type 2 diabetes * cardiovascular disease * hypertension * participation in diet or weight loss program in the 3 months prior to enrollment * psychiatric or sleep disorder * food allergies or intolerances * dislike of or unwillingness to eat test foods