Kornimate/medical-research-clean huggingface dataset:
impaired family dynamics leads to non compliance in type i diabetes

Conditions: Type 1 Diabetes

Summary: this study will test the hypothesis that certain parenting styles are associated with greater non-adherence to therapy in children and teens with type 1 diabetes. to test their hypothesis, the investigators will use standardized and validated questionnaires for parents and children to determine: parenting styles (the investigators will measure parental strictness, parental attachment, and parental monitoring), parent ability to cope with stress, parent comfort with the parenting role, parent and child level of depression and parent perception of financial resources. the investigators will also measure parent and child's perception of the child's underlying temperament and parent-child conflict. the investigators will correlate these findings with both parent and child subjective measures of adherence to therapy. the investigators will also obtain objective measures of therapy adherence including: hba1c, number of hospitalizations for diabetes ketoacidosis and number of missed outpatient appointments. these measures will be correlated with our other findings.


Eligibility criteria:
inclusion criteria: * type 1 diabetics * aged 9 - 18 years exclusion criteria: * none
safety and immunogenicity of novartis meningococcal acwy conjugate vaccine in healthy children aged 12-59 months.

Conditions: Meningococcal Meningitis

Summary: to compare the functional immune response 28 days after administration of one dose of men acwy-crm conjugate vaccine without adjuvant (menacwy-crm(ad-)) with that of a men acwy polysaccharide (ps) vaccine


Eligibility criteria:
inclusion criteria: * healthy 12-\<60 month old children; exclusion criteria: * subjects who have previously received any meningococcal vaccine * subjects with any serious acute or chronic progressive disease

Keywords: meningitis children vaccine
medico-economic study of the subglottic secretions drainage in prevention of ventilator-associated pneumonia (demeter)

Conditions: Ventilator-associated Pneumonia

Summary: in france, despite the implementation of bundles to prevent ventilator-associated pneumonia (vap) in the last decades, the vap incidence remains high above 10 per cent. in the last american recommendations of vap prevention, the drainage of subglottic secretions (ssd) has been notified among the "basic practices" to prevent vap. nevertheless, the diffusion of ssd in icus remains limited. this situation is largely due to the initial overcost of the specific endotracheal tubes allowing ssd and to the unavailability of these devices in medical units in which patients are intubated before the icu admission. so, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to vap prevention bundles in icu.


Eligibility criteria:
inclusion criteria: * age over 18 years * invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours * intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (ssd) will be available during the ssd period of the trial * information delivered exclusion criteria: * previous inclusion in the study * patients moribund at the icu admission * pregnant, parturient or breast-feeding woman * patient hospitalized without consent and/or deprived of liberty by court's decision * patient under guardianship or curators * lack of social insurance * concomitant inclusion in a trial on vap prevention * patient with no comprehension of the french language

Keywords: ventilator-associated pneumonia subglottic-secretions drainage critically ill patients cost-utility analysis prevention
study on microflora characteristics of pancreatic solid lesions via endoscopic ultrasound-guided fine needle aspiration/biopsy

Conditions: Pancreatic Carcinoma; Pancreatic Neuroendocrine Tumor; Autoimmune Pancreatitis; Microflora

Summary: study objective: to describe the microflora characteristics of the pancreatic solid lesions via the tissue acquired via the endoscopic ultrasound-guided fine needle aspiration/biopsy (eus-fna/b). study design: this is a prospective observational study.

this is a prospective observational study. patients who need eus-fna/b for diagnosis of pancreatic solid lesions (pancreatic cancer, chronic pancreatitis, and autoimmune pancreatitis, etc)will be successively included in this study. the eus-fna/b procedures will be accomplished in the standard way after the puncture site is washed with 20ml sterile saline for three times. the remaining fresh tissue after sufficient specimen collected for the diagnosis will be stored in - 80℃ fridge. dna is extracted from all samples using the suitable kit and v4 16s rrna gene sequencing is performed on all samples. the investigators ran "decontam" (davis nm, et al. microbiome 2018;6:226) in order to identify and remove contaminant dna sequences from the dataset. and the microbiome is analyzed with the standard methodology. the investigators tend to describe the microflora characteristics of pancreatic solid lesions and try to compare the differences between cancer and benign diseases. this study will carry out in two stages: the preliminary stage, 10 patients will be included. if the technic success rate (successful extraction of dna and sequencing of 16s rrna after bioinformatical removal of potential dna contaminations via the use of 'decontam') is high than 50%, the successive inclusion progress \[the main stage\] will last for one year.

Eligibility criteria:
inclusion criteria: * patients who need eus-fna/b for diagnosis of pancreatic solid lesions. * age ≥ 18 years and \< 80 years. exclusion criteria: * including but not limited to: poor general conditions, severe cardiopulmonary disease, difficult to tolerate eus examination; coagulation dysfunction; platelets \<50×10\^9/l

Keywords: pancreatic solid lesion microflora fine needle aspiration/biopsy
atrificial shrinkage of blastocyst before in vitro fertilization

Conditions: Infertility

Summary: vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° c in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing

vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° c in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing unlike the slow freezing method, vitrification has better results in a complete elimination of ice crystal inside the cells as well as in the surrounding solution -also, it has a significantly higher post-thawing survival rate in comparison to slow freezing method

Eligibility criteria:
inclusion criteria: * women with infertility from 20 to 44 years exclusion criteria: * women with age more than 44 or less than 20
a study to evaluate the efficacy and safety of roxadustat for the treatment of anemia in participants receiving chemotherapy treatment for non-myeloid malignancies

Conditions: Chemotherapy Induced Anemia

Summary: the main goal of this study is to evaluate the efficacy of roxadustat for treatment of anemia in participants with non-myeloid malignancies receiving multi-cycle treatments of myelosuppressive chemotherapy.

participants who are eligible for participation will be randomized to roxadustat and sepo® (recombinant human erythropoietin-α \[rhuepo-α\]), and undergo a 12-week treatment period followed by a 4-week follow-up period.

Eligibility criteria:
key inclusion criteria: * diagnosis of non-myeloid malignancy, by histological or cytological confirmation. * anemia related to myelosuppressive chemotherapy, defined as hb ≤100 g/l at screening with documented participant's hb level decrease ≥10 g/l after the initiation of chemotherapy as judged by the investigator. * planned concurrent treatment of cancer (myelosuppressive chemotherapy) for at least 8 additional weeks. * body weight ≥40 kg. * eastern cooperative oncology group (ecog) performance status of 1 or 2. * ferritin ≥50 nanograms (ng)/milliliter (ml) and transferrin saturation (tsat) ≥10%. key exclusion criteria: * participants with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. * participants who are only receiving hormonal products, biological products, novel immunosuppressive products (such as programmed cell death protein-1 \[pd-1\] and programmed death-ligand 1 \[pd-l1\] checkpoint inhibitors) or targeted biological or radiation therapy to treat/manage their cancer, however if chemotherapy is co-administered with these products, then it is acceptable to enroll the participant. * participants with hematocrit (hct) ≥36%. * participants who have received an rbc transfusion or esa within 4 weeks of randomization. * thromboembolic event (including but not limited to deep vein thrombosis \[dvt\], pulmonary embolism, myocardial infarction, stroke, transient ischemic attack \[tia\] within previous 6 months of screening. * clinically significant anemia due to other etiologies such as iron deficiency, vitamin b12 or folate deficiency, autoimmune anemia, hemolysis, hemorrhage, or hereditary anemia such as sickle cell anemia or thalassemia. * the investigator judges that the participant will be unable to fully participate in the study and complete it for any reason, including inability to comply with study procedures and treatment, addiction, or any other relevant medical conditions. note: other inclusion and exclusion criteria may apply.
effect of nano care gold on marginal integrity of resin composite

Conditions: Caries Class Ii

Summary: the aim of this study to detect the effect of nano care gold on marginal integrity of resin composite restoration

this study will be divided into 3 groups (control, nano care gold, chlorhexidine). both materials will be used as a surface pre-treatment. their effect on marginal integrity will be evaluated through evaluation of marginal adaptation, marginal staining, post-operative sensitivity. the follow up period is one year

Eligibility criteria:
inclusion criteria: * (1) patients with at least two class ii cavities (2) 17-50 years old (3) males or females (4) good or hygiene (5) good general health (6) cooperative patients (7) subjects who signed the informed consent exclusion criteria: 1. patients younger than 17 years or older than 50 years old 2. pregnant females 3. disabilities 4. systemic disease or severe medical complications 5. heavy smoking 6. lack of compliance

Keywords: marginal adptation marginal staining post operative sensitivity recurrent caries
efficacy, tolerability, and comfort of 0.3% hypromellose eyedrops in patients undergoing lasik surgery

Conditions: Dry Eye

Summary: this study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in lasik surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in lasik surgery patients compared to control (no pre-operative lubricant).


Eligibility criteria:
inclusion criteria: * age 21 - 35 * both sexes * seeking lasik surgery at the refractive surgery centre * meeting all established criteria for appropriateness for lasik established by the treating center exclusion criteria: * any corneal pathology including scars, prior herpes keratitis, prior corneal transplant * any immuno-compromised state including cancer, hiv infection, hepatitis b or c, or diabetes mellitus * requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment * anticipated refusal or inability to undergo planned post-operative visits or assessment * failure to meet all established criteria for appropriateness for lasik

Keywords: post lasik dry eye pre lasik dry eye hypromellose
cognitive rehabilitation in post-covid-19 condition

Conditions: COVID-19

Summary: post-covid-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (efs). goal management training (gmt) is a cognitive rehabilitation (cr) intervention for improving attention and efs that has received empirical support in studies of other patient groups. the present study aims to determine the efficacy of gmt for improving everyday attention and efs in adults who experience persistent cognitive deficits after covid-19. the study is a randomized controlled trial (rct), comparing the efficacy of gmt to a wait list control condition (wl), for improving persistent cognitive sequela in post-covid-19 condition. the study aims to recruit 120 participants aged 18 to 65 years with a history of laboratory- or home-test confirmed, sars-cov-2 infection and perceived attentional and ef difficulties in daily life that have lasted for at least two months and that cannot be explained by an alternative diagnosis. participants will be randomized to either group-based gmt (n = 60) or wl (n = 60). gmt will be internet-delivered to groups of six participants in six two-hour sessions delivered weekly (five weeks). the primary outcome will be the metacognition index of the behavior rating inventory of executive function - adult version, a self-report measure assessing everyday ef difficulties, at six months post-treatment. secondary outcomes include performance-based neurocognitive measures and rating scales of cognition, emotional health, quality of life, and fatigue. secondary aims include to explore to what extent potential early change predicts outcome, and to examine what characterize those who profit from gmt, in addition to describe the neurocognitive and emotional health in a covid-19 sample. the investigators will also examine potential effects of gmt at 2- and 5-year follow-up.


Eligibility criteria:
inclusion criteria: * history of laboratory- or home-test confirmed, sars-cov-2 infection * perceived cognitive difficulties (attention, memory, ef) affecting everyday functioning that have lasted for at least two months and that cannot be explained by an alternative diagnosis * age between 18-65 years exclusion criteria: * ongoing alcohol- or substance abuse, premorbid insult and/or comorbid neurological disease, severe neurocognitive problems interfering with the capacity to participate, sensory disorders biasing cognitive assessment, psychotic disorders, lack of proficiency in norwegian, and being previously enrolled in a gmt trial.

Keywords: rehabilitation
bioequivalency study of 7.5 mg pilocarpine tablets under fasting conditions

Conditions: Dry Mouth

Summary: the objective of this study was the bioequivalence of a roxane laboratories' pilocarpine tablets, 7.5 mg, to salagen® tablets, 7.5 mg (mgi) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to pilocarpine or any comparable or similar product.
reproductive options in inherited skin diseases

Conditions: Ichthyosis; Palmoplantar Keratoses; Epidermolysis Bullosa; Ectodermal Dysplasia; Basal Cell Nevus Syndrome; Birt-Hogg-Dube Syndrome; Tuberous Sclerosis; Xeroderma Pigmentosum; Cutis Laxa; Albinism

Summary: the goal of this observational study is to learn about the indications for prenatal diagnostics and preimplantation genetic testing for patients/couples affected by an inherited skin disease, and evaluate the clinical outcomes of these reproductive options. by providing a complete overview, the investigators aim to improve reproductive counselling for these patients/couples with a desire to have children. to achieve this, the investigators aim to retrospectively collect data from a cohort of patiens/couples affected by an inherited skin disease on a national level (in the netherlands) and also an international level from various countries in europe.


Eligibility criteria:
inclusion criteria: * couples affected with molecularly confirmed genodermatosis (i.e., keratinisation disorders, skin fragility diseases, ectodermal dysplasias, dermato-oncological syndromes, other genodermatoses) * prenatal diagnosis (pnd) was performed and/or in vitro fertilisation (ivf) with pre-implantation genetic testing was performed (pgt). exclusion criteria: * no exclusion criteria were formulated.
mld10 for the treatment of hypomagnesemic patients with type 2 diabetes mellitus

Conditions: Hypomagnesemia in Type 2 Diabetic Patients

Summary: to determine the effect of mld10 (magnesium l-lactate dihydrate extended-release caplets) 10 meq bid on serum magnesium in type 2 diabetic patients with hypomagnesemia.


Eligibility criteria:
inclusion criteria: * females and males with type 2 diabetes mellitus * body mass index between 18 to 40 kg/m2, inclusive, at screening * hypomagnesemia defined as serum magnesium ≤ 1.5 mg/dl at screening * females must be non-pregnant, non-lactating, and have a negative serum pregnancy test before enrollment. exclusion criteria: * history of clinically significant gi, renal, hepatic, neurologic, hematologic, endocrine other than type 2 diabetes mellitus, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease.
preventing catheter-related bacteremia when administering injectable medications in premature infants.

Conditions: Bacteremia; Infant, Very Low Birth Weight

Summary: this study evaluates the potential interest of a new multi-lumen infusion access device (edelvaiss® multiline neo) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants. this device will be compared to the standard infusion set of each center.

edelvaiss® multiline neo is a multi-lumen infusion access device, adapted to the neonatal population. it has five ports connected to five lumens separated in a single tube of 90 cm, combined with a small single tube called annex port. four ports numbered 1 to 4 are connected to four peripheral lumens (residual volume per lumen: 0.6 ml). the fifth port, called central access (indicated by the hf icon (high flow)), is reserved to the administration of parenteral nutrition. it is connected to the central lumen (residual volume: 4.5 ml). the sixth port on the annex way allows an administration closer to the infant (residual volume: 0.40 ml). it is thus reserved for emergencies and direct intravenous injections. the innovative technological design of edelvaiss® multiline neo device should enable secure administration of injectable drugs by preventing variations in drug mass flow rate and the occurrence of drug incompatibilities. this device would reduce the number of perfusion incidents and therefore, the frequency of manipulations of infusion lines within the incubator, direct source of occurrence of bacteremia. moreover, its main interest lies in neonatology in the possibility of being positioned outside of the incubator and to have a lifetime of 21 days, contributing to the prevention of catheter-related bacteremia. all manipulations are therefore made outside the incubator at the room temperature and the relative humidity, and at a distance from the device/catheter junction.

Eligibility criteria:
inclusion criteria: * infants with gestational ages between 24 and 29 weeks. * infants carrying a single-lumen central venous catheter. * obtaining the informed parental consent. exclusion criteria: * infants carrying a multi-lumen central venous catheter. * infants carrying a umbilical venous catheter. * infants carrying two central venous catheters. * refusal of informed parental consent.

Keywords: premature infants catheter-related bacteremia infusion device neonatal intensive care central venous catheter drug infusion systems
oscar health patient pings

Conditions: Emergency Room Utilization

Summary: oscar spends a significant amount of money every year on high cost high need individuals. with this increase in health care spending, oscar health is looking to expand care post emergency room and inpatient utilization for their members. in order to reduce hospital readmissions, reduce emergency room utilization, and increase the overall health of their members, oscar is investing in a program to bring members better care through increased engagement with their primary care physician.

using their existing technology, oscar is employing a randomized controlled trial among their physicians to improve their engagement and relationships with patients. the goal will be to test and refine patient pings as a provider engagement tool, with an eye toward using it within the broader approach to high-risk patients as well. the penn team is helping to design the intervention, which includes helping with determining what the three arms will be and randomizing physicians and practice sites. they will implement a three-arm trial with the first arm being usual care (no pings), the second arm being the intervention of information, and the third arm being the intervention of information and financial incentives. in the two intervention groups, providers will be sent patient pings after a patient experiences a trigger event. this trigger event could be an emergency room visit, admission to a hospital, or a hospital discharge event. the patient ping will be sent to the patients doctors including primary care physicians and specialists. if the patient does not have a doctor, a ping will not be sent. in the third arm, physicians will be incentivized to see patients immediately via phone call or in office visit. physicians will receive an incentive for calling the member within 48 hours of trigger event and will receive a larger financial incentive for seeing the patient for an office visit within 7 days of trigger event. this bonus payment will be paid to physicians uncoupled from usual reimbursement as a separate bonus check to increase salience. no pings will be sent to the physicians for the patients randomized to arm 1: usual care.

Eligibility criteria:
inclusion criteria: * primary care and specialist physicians under contract with oscar health insurance exclusion criteria: * any primary care and specialist physician not under contract with oscar health.