Kornimate/medical-research-clean huggingface dataset:
organizing the information given to parents of nicu infants in order to reduce their anxiety

Conditions: Anxiety

Summary: being a parent to a premature infant in nicu is an anxious state. parents ask a lot of questions, and look for information all the time. organizing the information given to parents could reduce their anxiety. the parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. of course, questions will be answered all the time. the parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

being a parent to a premature infant in nicu is an anxious state. parents ask a lot of questions, and look for information all the time. organizing the information given to parents could reduce their anxiety. the parents will be divided into two groups: one group will get organized information, by a lecture at the first week of their infant's life, and the other group will not. of course, questions will be answered all the time. the parents will answer a questionnaire on the first week of the infant's life, and on the last week, just before releasing the infant home.

Eligibility criteria:
inclusion criteria: * parents to premature infants, after releasing the mother exclusion criteria: * term infants * hospitalized mother

Keywords: anxiety parents nicu prematurity anxiety of parents to nicu infants
simulation of facial soft tissue in orthognathic surgery

Conditions: Orthognathic Surgery

Summary: orthognathic surgery consists of rebalancing the position of the jaws, taking into account functional criteria (tooth engagement, tooth/lip ratio, breathing, etc.) and aesthetic criteria. it has become much more accurate in recent years thanks to the advent of osteosynthesis plates and the contribution of three-dimensional imaging. three-dimensional imaging makes it possible to simulate fairly accurately the surgical procedures and bone displacements required. however, the effect of these bone displacements on the soft tissues (skin, subcutaneous tissue, muscles) does not make it possible, with today's digital tools, to simulate the final aesthetic result and in particular to anticipate the sometimes significant postoperative changes to the face. many patients are worried about these post-operative morphological changes and would like to have a precise idea of how they will look after surgery. being able to offer them, before surgery, a visual solution simulating the final aesthetic appearance would be essential in this respect. the aim of the study is to validate the predictions provided by the digital face model on a series of patients scheduled for orthognathic surgery by comparing the simulation of the morphological result of the operation, provided by our algorithm (spoc), with the actual result assessed on a scan taken 6 months after the operation.


Eligibility criteria:
inclusion criteria: * patient over 18 ; * patients who have been informed of the study and who have freely given their informed consent to participate in the study; * patient undergoing isolated mandibular or maxillary orthognathic surgery, or maxillo-mandibular surgery with or without genioplasty for any indication (occlusal disorder, sleep apnoea syndrome, functional joint disorder, etc.); * patient covered by a french social security scheme exclusion criteria: * patient with maxillary disjunction ; * patients with facial malformations; * pregnant or breast-feeding patient; * patient under guardianship; * patients who do not understand french; * patients under court protection * no pre- or postoperative ct scan or ct scan that cannot be used * surgery, trauma, progressive infection or cosmetic injection on the face after orthognathic surgery and before the postoperative scan
a study to collect data to build artificial intelligence derived algorithms for estimating iron status of children

Conditions: Iron Deficiency

Summary: an exploratory study to collect data to build artificial intelligence derived algorithms for estimating iron status in children

this is an exploratory, observational, pilot study that aims to build and measure the accuracy of an algorithm that estimates a child's iron status using images and/or videos, against gold standard venous blood sampling. images and/or videos will be collected by healthcare professionals, together with blood test results. this data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. data on the acceptance and experience of the using the algorithm will be collected for improvements.

Eligibility criteria:
inclusion criteria: 1. children above 6 months of age and below 6 years of age 2. written consent from parent(s) or legally acceptable representative(s), who themselves are aged ≥ 21 years old, to consent and comply with the terms and conditions of the study 3. parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires 4. parent(s) should be able to comprehend the content of the study and complete the study questionnaires 5. parents(s) must be comfortable with their child having blood draws 6. subject has a hb level corresponding to a hb group with open slots for participation exclusion criteria: 1. children with any medical condition that in the opinion of the investigator would not be suitable for enrolment. 2. children with nail bed obstructions, nail polish, nails discolouration (e.g., leukonychia, melanonychia, bruising, etc.), or scarring of the lips, pigmentations on lips for thyroid dysfunction (e.g., puettz-jeghers syndrome). 3. children who are unable to cooperate with study procedures. 4. employees and/or children/family members or relatives of employees of danone global research \&amp; innovation center or the participating sites.

Keywords: algorithm artificial intelligence iron deficiency ida anemia
anterior abdominal blocks for postoperative pain control in obese patients

Conditions: Postoperative Pain

Summary: the purpose of this study is to compare between two surgical techniques for anterior abdominal wall blocks in obese patients undergoing major gynecological surgery: surgical transversus abdominis plane \[tap\] block versus rectus sheath block as regards the efficacy and adverse effects


Eligibility criteria:
inclusion criteria: * female patients * undergoing major gynecological surgery with supraumbilical midline incision the first time * body mass index (bmi) more than 40. exclusion criteria: * patient refusal to participate in the study, * reoperation, * addiction * alcohol abuse * hypersensitivity or allergy to the study drugs
the willow lte study with m5049 in participants with scle, dle and/or sle (willow lte)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of the study is to evaluate the long term safety and efficacy of orally administered m5049 in participants with subacute cutaneous lupus erythematosus (scle), discoid lupus erythematosus (dle) and/or systemic lupus erythematosus (sle) who have completed the 24 week treatment period of willow study (ms200569_0003 \[nct05162586\]).


Eligibility criteria:
inclusion criteria: * are active scle, dle and/or sle that have completed the 24 week treatment of the willow study * have a body mass index (bmi) within the \>= 40 kilograms per meter square (inclusive) at screening * other protocol defined inclusion criteria could apply exclusion criteria: * participants who experienced serious event(s) related to the study intervention during the willow study * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with long term extension (lte) study participation * ongoing or active clinically significant viral (including severe acute respiratory syndrome coronavirus 2 \[(sars-cov-2)\], bacterial or fungal infection, or any major episode of infection requiring hospitalization * received lte prohibited medication during the willow study or after the willow study week 24 * participation in any other investigational drug study after the willow study week 24 * other protocol defined exclusion criteria could apply

Keywords: toll-like receptor 7 toll-like receptor 8 willow adults sle cle lupus discoid lupus erythematosus subacute cutaneous lupus erythematosus m5049 enpatoran lte
electrophysiological effects of irbesartan in patients with paroxysmal atrial fibrillation (af)

Conditions: Atrial Fibrillation

Summary: the main purpose of the study is to compare the mean aerp between treatment groups based on the hypothesis that in subjects with paroxysmal af, irbesartan prevents electrophysiological remodeling resulting in a prolonged atrial effective refractory period relative (aerp) to placebo.


Eligibility criteria:
inclusion criteria: * recurrent paf with indication for catheter ablation exclusion criteria: * struct. cardiopathy * mitral valve disease * vef\<40% * myocardiopathy * lvh * cardiac surgery * af reversible * qt c\>450 * recent mi/stroke, severe htn * requirement of acei/arbs * coronary synd., hta, liver disease

Keywords: patients with paroxysmal atrial fibrillation (paf)
alhiv smartphone game study

Conditions: Hiv; AIDS; Adolescent Behavior; Treatment Compliance; Treatment Adherence; Reproductive Behavior; Sexual Behavior

Summary: this is a cluster-randomized controlled trial that aims to conduct comprehensive feasibility testing of a smartphone game in a sample of 120 adolescents living with hiv (alhiv) ages 15-21 in kisumu, kenya, to determine whether the game influences behavioral mediators of engagement in care and sexual risk avoidance and reduction (including knowledge, attitudes, behavioral intentions, and self-efficacy).

this is a cluster-randomized feasibility study that will involve clinic-level randomization of 120 alhiv participants (12 from each of 10 clinical centers). participants will either use the intervention (a smartphone game) or continue standard treatment and support for hiv. participants will complete 5 surveys about behaviors, attitudes, knowledge, and self-efficacy relating to engagement in care, art adherence, and sexual and reproductive health. they will also have blood drawn 3 times to measure their hiv viral load. intervention-arm participants will also complete app experience surveys. a sample of intervention-arm participants will be invited to provide feedback on their experience in interviews (n=10) and/or focus groups (n=30).

Eligibility criteria:
adolescents, male and female, aged 15-21 in kisumu county (n=120) inclusion criteria: * aged 15-21 at time of recruitment * diagnosed with hiv and aware of hiv status * initiated art at least 6 months prior * accesses hiv-related care at intervention arm ccc * vl above 50 copies/ml at last test, with last test conducted within 12 months prior to recruitment date exclusion criteria * does not have basic literacy in english (grade 3-4 on the flesch-kincaid reading scale) * sibling to an adolescent already enrolled in study * sibling to adolescent that participated in formative research * participant in formative research to inform study * participant in any tumaini game activities * enrolled in boarding school * last recorded viral load test \>12 months prior to recruitment date

Keywords: hiv smartphone game
a study to examine the effects of the leptin receptor (lepr) agonist antibody regn4461 in adult patients with familial partial lipodystrophy (fpld)

Conditions: Familial Partial Lipodystrophy; Metabolic Abnormalities

Summary: two cohorts are being studied based on leptin levels. cohort a is composed of patients with baseline leptin \<8.0 ng/ml and cohort b is composed of patients with baseline leptin 8.0 to ≤20.0 ng/ml the primary objectives will be evaluated for patients in cohort a only: * to evaluate the effect of regn4461 on fasting triglycerides (tg) in patients with elevated baseline fasting tg * to evaluate the effect of regn4461 on hyperglycemia in patients with elevated baseline hemoglobin a1c (hba1c) the following secondary objectives of the study will be evaluated for cohort b and for the combined set of cohorts a plus b: * to evaluate the effect of regn4461 on fasting tg levels in patients with hypertriglyceridemia * to evaluate the effect of regn4461 on glycemic control in patients with hyperglycemia the following secondary objectives of the study will be evaluated for cohorts a and b separately, and for the combined set of cohorts a plus b: * to evaluate the effect of regn4461 on liver fat in patients with hepatic steatosis * to evaluate the effect of regn4461 on hunger * to evaluate safety and tolerability of regn4461 * to characterize the concentration profile of regn4461 over time * to assess immunogenicity to regn4461


Eligibility criteria:
key inclusion criteria: * clinical diagnosis of familial partial lipodystrophy as defined in the protocol * fasting leptin level ≤20.0 ng/ml, as determined during the screening period * presence of significant metabolic abnormalities related to glucose and triglycerides (tgs) as defined in the protocol * stable body weight within the 3 months prior to screening (no gain or loss of \>5% current weight) * stable diet during the past 3 months defined as no major change in macronutrient composition (eg, starting or stopping diets such as atkins, paleo, vegetarianism, veganism) * no clinically meaningful change in medication regimen in the 3 months prior to screening as defined in the protocol key exclusion criteria: * treatment with metreleptin within 3 months of the screening visit * patients with a diagnosis of generalized lipodystrophy * patients with a diagnosis of acquired lipodystrophy * pregnant or breastfeeding women note: other protocol defined inclusion/exclusion criteria apply
p2 multi-center study of sb204 gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: this is a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. subjects will be treated for up to 12 weeks.

a randomized, multi-center, double-blinded study in subjects with moderate to severe acne vulgaris. subjects eligible to enroll will be treated once or twice daily with 2 concentrations of a topical drug in development or a vehicle. subjects will be treated for up to 12 weeks.

Eligibility criteria:
inclusion criteria: * moderate to severe acne * 25-70 non-inflammatory lesions at baseline * 20-40 inflammatory lesions at baseline exclusion criteria: * subjects with known allergy to any component of the test material or vehicle * women who are pregnant or nursing

Keywords: acne
does letrozole improve the outcomes and/or reduce the cost of ivf-et cycles?

Conditions: Infertility

Summary: this research is being done to determine whether the success rate of in vitro fertilization treatment can be improved, while lowering the cost incurred from infertility medications using a pill called letrozole.

specific aim: 1. to determine whether addition of letrozole to gonadotropins would reduce the amount of gonadotropins used in an ivf-et cycle, thereby reducing the cost. 2. to determine whether letrozole improves ivf-et success compared to standard ovarian stimulation protocols. null hypothesis: use of letrozole for ovulation induction in ivf is not less expensive than the standard therapy by a clinically relevant amount. alternative hypothesis: use of letrozole for ovulation induction in ivf is better than the standard therapy by a clinically relevant amount. protocol: infertile women \<40 years of age with age-appropriate ovarian reserve (as determined by day2/3 e2, fsh, and amh) will be randomized between two protocols: one with letrozole and one with standard ovulation induction. in both groups, serum fsh will be measured each time a sample is obtained for estradiol. sera will be frozen for further batch assay. number of embryos to be transferred will be decided following the asrm guidelines. the day of embryo transfer (d-3 vs d-5) will be based on the number and quality of embryos as per established clinical criteria. power considerations a review of 1473 cycles of patients less than 40 years old over the last 6 years (2002 - 2008) revealed average cost per cycle to be $3,152 +/- 1685(sd). for the purpose of this power analysis we consider a 20% decrease in medication cost to be clinically significant. thus a decrease from $ 3152.83 to $ 2522.26 will be considered clinically significant (20% decrease). for an alpha of 0.05 and a power of 80% for a two tailed test 113 patients will need to complete each arm. allowing for 10% drop-out we will attempt to randomize 125 patients to each arm of the study.

Eligibility criteria:
inclusion criteria: 1. normal ovarian function 2. normal uterus exclusion criteria: 1. age 40 and above 2. diminished ovarian reserve (based on markers and/or previous poor response) 3. previous oophorectomy

Keywords: cost of infertility treatment ovulation induction letrozole in vitro fertilization
structural and functional connectivity in partial epilepsies studied with mri and meg

Conditions: Epilepsies

Summary: surgery may be an effective therapy for refractory focal epilepsies with a clear delineated focus but surgical benefits are less clear for patients with a poorly defined focus such as non lesional refractory partial epilepsies. seeg is considered the criterion standard to localize the epileptogenic zone (ez) but the procedure is risky with a limited spatial sampling. the development of non-invasive neuroimaging alternatives is thus an important goal to improve ez delineation and optimize seeg procedures. the main hypothesis of this research project is the existence of a network organization specific for each patient which allows the generation and propagation of epileptic activities. the investigators wish to explore this network using diffusion tensor mri to study structural connectivity and meg/fmri to study functional connectivity. the investigators will apply tools from the theories of complex networks and dynamical systems to characterize the network organization of epileptic process. the investigators aimed to identify and localize differences in connectivity parameters between individual patients and a control group of healthy volunteers.


Eligibility criteria:
inclusion criteria: * intracranial eeg recordings scheduled * no neurological or psychiatric disease for healthy volunteers exclusion criteria: * contraindication to mri * pregnancy

Keywords: refractory partial epilepsies
risk factors for postoperative complications in major non-cardiac surgery: post-hoc analysis of the ophique multicentre study

Conditions: Goal Directed Therapy; Postoperative Morbidity; Individualised Target; Postopera Mortality

Summary: post-operative morbidity and mortality is related to many factors related to the patient's condition, the intra-operative period and the optimisation of intra-operative haemodynamic and respiratory parameters. many studies have looked at the determinants and factors that increase postoperative complications. however, these have been randomised studies looking at one parameter in particular. this analysis would be the first to investigate the determinants of postoperative complications in a large population of patients undergoing major non-cardiac surgery. this is a post-hoc analysis of patients included in the ophique study, whose main objective was to evaluate intraoperative haemodynamic management guided by a marker of tissue hypoperfusion (the respiratory quotient).


Eligibility criteria:
inclusion criteria: * abdominal, orthopaedic or vascular surgery under general anaesthesia and with an estimated duration of surgery \> 2 hours * adult patients (age ≥ 18 years) * asa score ≥ ii * patient with at least two of the following comorbidities: age \> 50 years, high blood pressure (hta), heart failure, ecg abnormality, smoking, stroke, transient ischemic attack (tia), peripheral arterial disease (pad), insulin-dependent or non-insulin-dependent diabetes mellitus (niddm), ascites, chronic renal failure (crf) * signature of the consent form * affiliation to a social security scheme exclusion criteria: * severe untreated or unbalanced hypertension * preoperative renal failure on dialysis * acute heart failure * acute coronary insufficiency * vascular surgery with renal plasty * cardiac surgery * permanent laparoscopy * chronic respiratory failure with home oxygen therapy * acute respiratory distress syndrome with fio2\>60%. * preoperative shock * surgery under spinal anaesthesia and epidural only * refusal to participate by the patient * pregnant, parturient or breastfeeding women * patients under guardianship or curators, under court protection or deprived of public rights * the patient already included in another therapeutic trial with an experimental molecule * emergency surgery * patients who do not want their personal data to be used in the framework of the research

Keywords: goal directed therapy postoperative morbi-mortality individualised target
the exercise capacity and quality of life in the patients with ipah and secondary ph

Conditions: Hypertension, Pulmonary

Summary: pulmonary hypertension (ph) is a progressive disease with high mortality rate, but due to the development of drugs, the prognosis of the disease has improved. however patients still have poor exercise capacity and decrease of the quality of life. past studies have shown that idiopathic and secondary ph are different in etiology and prognosis. it is necessary to further understand the difference between exercise capacity and quality of life of these two types of patients.

background. pulmonary hypertension (ph) is a progressive disease with high mortality rate, but due to the development of drugs, the prognosis of the disease has improved. however patients still have poor exercise capacity and decrease of the quality of life. past studies have shown that idiopathic and secondary ph are different in etiology and prognosis. it is necessary to further understand the difference between exercise capacity and quality of life of these two types of patients. purpose. the purpose of this study is the comparison of idiopathic and secondary ph in exercise capacity and quality of life, and analyzed the factors affecting. method. the patients recruit from national taiwan university hospital. thirty patients who diagnosis with ph and willing to participant our study will recruited. according to the cause of disease patients will divided into two groups, idiopathic group and secondary ph group has fifteen patients. both of group receive testing, including body composition, exercise capacity (six minutes walk test, cardiopulmonary exercise testing), record their regular physical activity( seven day physical activity recall questionnaire) , fatigue severity(fatigue severity scale), and quality of life (sf-36), monitor cardiac function (non-invasive cardiac output test instrument). data are analyze using spss19.0 version. data will be presented in mean ± standard deviation and percentage. using kolmogorov-smirmov test to test, whether the data were normal distribution, when p\> 0.05 is considered as a normal distribution. mann-whitney u test or chi-square test to processing parameters between two groups. independent sample t test will be used to compare whether there are between-group differences. pearson correlation coefficient will be used to test correlations between the parameters. the study defines significant level at α = 0.05, two-tailed.

Eligibility criteria:
inclusion criteria 1. diagnose as pulmonary hypertension 2. clinical stable over 3 months 3. able to walk and can perform cardiopulmonary exercise testing by bicycle exclusion criteria 1. acute right heart failure 2. sever arrythmia 3. the history of exercise induce syncope

Keywords: cardiopulmonary exercise testing right ventricle function cardio output pulmonary hypertension quality of life