Kornimate/medical-research-clean huggingface dataset:
early intervention based on neonatal crawling in very premature infants at risk for neurodevelopmental disorder

Conditions: Prematurity; Extreme Prematurity; Infant Development; Brain Damage; Motor and Developmental Delay

Summary: extreme prematurity is constantly increasing according to the world health organization. however, methods to train premature infants at risk of disability is sorely lacking. the goal of this project is to overcome this problem. in previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the crawliskate (a new tool that the investigators designed and patented ep2974624a1), is an excellent way to stimulate infants' motor and locomotor development. this method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants. the specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay. methodology: the investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions. these infants will be recruited before their hospital discharge at the nicu. after their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the crawliskate every day for 2 months (crawli group), and one group of infants will receive regular medical care (control group). all infants will be tested for: 1)their crawling proficiency on the crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (ca, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months ca (2d and 3d recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months ca: bsid iii edition, asq-3, amiel-tison's neurological assessment, prechtl assessment of general movements. one more asq-3 questionnaire will be provided at five years. expected results: the first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the nicu) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.


Eligibility criteria:
inclusion criteria: * term between 24-26 ga or 26-32 ga with suspected brain lesion * parental consent * family living in intervention area * good tolerance on the first crawliskate trial exclusion criteria: * no bronchodysplasia defined by oxygen dependency after 36 ga * no medical disease * no limb deformity * no karyotype anomaly * no visual or auditory impairment

Keywords: prematurity crawling early intervention motor development locomotion
is the ivf outcome dependent on the time interval between hcg administration and oocyte retrieval?

Conditions: Subfertility

Summary: during controlled ovarian hyperstimulation (coh), human chorionic gonadotrophin (hcg) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of lh. the hcg is administered when more than three follicles ≥17mm in mean diameter have developed. the time interval between hcg administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation. the commonly practiced hcg administration time of 33 to 36 h in most ivf cycles aims to avoiding spontaneous ovulation before oocyte retrieval. however, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hcg-to-oocyte interval of 38 h. it has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation. currently there are no data on the effect of the time interval between hcg administration and oocyte retrieval on ivf outcome in gnrh antagonist cycles. the aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hcg administration


Eligibility criteria:
inclusion criteria: * women undergoing fresh ivf cycle with recombinant fsh and gnrh antagonists * regular spontaneous menstrual cycle (24-35 days) * age ≤ 43 years * fsh ≤ 20 iu/l exclusion criteria: * history of previous ovarian surgery * women with stage iii-iv endometriosis * women undergoing natural cycle ivf

Keywords: ivf, hcg, oocyte retrieval, time interval
peri-incisional drug injection in lumbar spine surgery

Conditions: Lumbar Disc Herniation; Degenerative Disc Disease; Spondylolisthesis

Summary: this is a randomized prospective study that will compare the use of narcotics in a control group of non-injected patients with a treatment arm of patients injected intra-operatively with a ropivacaine, morphine, and epinephrine cocktail. the investigators hypothesize that this treatment will reduce narcotic use in patients during their hospital stay, and possibly decrease the length of their stay in the hospital.the investigators also hope their pain will be decreased as displayed by their multi-daily clinically aligned pain assessment (capa) score.


Eligibility criteria:
inclusion criteria: * any adult patient 18 years of age and older who is undergoing surgery for a lumbar spine problem. common diagnoses in this category would include lumbar disc herniations, spinal stenosis, and spondylolisthesis, but this is not an exhaustive list. exclusion criteria: * patients with comorbidities excluding use of proposed injection. * patients with major head trauma such that they cannot provide consent or describe their post-operative pain. * patients with other surgical treatment during study treatment (i.e. more than 1 surgery during the study period or within 30 days prior to surgery). * pregnant women (as assessed by pre-operative pregnancy test, which is standard of care). * patients with dementia such that they cannot provide consent or describe their post-operative pain. * patients with an allergy to study medications. * patients with previous drug dependencies. * any patient that refuses to be randomized or does not wish to enroll. * vulnerable populations, such as prisoners. * patients with a fracture, tumor, or infection as their primary diagnosis. * patients undergoing a deformity correction. * patients with surgeries extending more than 4 levels, with surgeries that extend to the pelvis, or with surgeries that cross the thoracolumbar junction.
salivary c- reactive protein, mean platelet volume and neutrophil lymphocyte ratio as diagnostic markers for neonatal sepsis

Conditions: Neonatal Sepsis

Summary: to evaluate reliability of salivary c-reactive protein ,mean platelet volume , neutrophil -lymphocyte ratio , and platelet lymphocyte ratio in diagnosis of neonatal sepsis


Eligibility criteria:
inclusion criteria: * - full term neonates of both genders from birth to the 28th day of life diagnosed with sepsis by history, clinical findings, laboratory findings, and blood culture. the clinical findings included the presence of three or more of the following: * (1) temperature instability (hypothermia, hyperthermia) . * (2) respiratory alterations (grunting, intercostal retractions, apnea, tachypnea, cyanosis) . * (3) cardiovascular alterations (bradycardia, tachycardia, poor perfusion, hypotension) . * (4) neurologic alterations (hypotonia, lethargy, seizures) * (5) gastrointestinal alterations (feeding intolerance, abdominal distension). crp values \>10 mg/l were considered to be positive. exclusion criteria: * - preterm neonates . * neonates with cns malformations, metabolic disorders, chromosomal abnormalities, intrauterine growth restriction, or birth asphyxia were excluded from the study
candida antigen and bivalent hpv vaccine in the treatment of multiple warts

Conditions: Warts; Human Papilloma Virus

Summary: to follow up the efficacy and safety of candida antigen, bivalent hpv vaccine in treatment of common warts either mono or combined intralesional therapy

* group a: 54 patients will be treated with candida antigen. all patients will be directly injected with candida antigen into the largest wart using an insulin syringe. injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. * group b: 54 patients will be treated with bivalent hpv vaccine solution intralesional into the largest wart using an insulin syringe. injections will be done at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. * group c: 54 patients will be treated with both agents intralesionally into the largest wart using an insulin syringe at 2-week intervals until complete clearance will be achieved or for a maximum of five treatment sessions. it is thought that candida antigen act through a cell-mediated immune response and bivalent hpv vaccine act mainly through humoral immunity, so we want to study their effect as single or mixed agents

Eligibility criteria:
inclusion criteria: * patients with multiple, recalcitrant, or non-recalcitrant common warts of different sites, sizes, duration, and with or without distant lesions will be enrolled in the study exclusion criteria: * pregnant female. hypersensitivity to candida antigen or bivalent hpv vaccine
enriched yogurts with soluble fibre or vegetable protein on satiety

Conditions: Overweight

Summary: the purpose of this study is to evaluate the satiating effects of different functional yogurts enriched with soluble fiber or vegetable protein on overweight subjects (bmi ≥25 and \<30 kg / m2). some studies have shown the contribution of high-fiber foods in the reduction of the cardiovascular risk. on the other hand, protein consumption could have a greater satiety potential compared to other macronutrients.

a randomized, cross-over and double-blind pilot study with 3 study arms is being performed to evaluate the satiating properties of different functional enriched yogurts with soluble fiber or vegetable protein in a group of healthy overweight subjects. the investigators included 12 participants (6 men and 6 women) between 18 and 55 years (bmi ≥25 and \<30 kg / m2). all volunteers will be randomized into 3 study groups, and participants will receive the 3 different study products in order during the 3 experimental phases.

Eligibility criteria:
inclusion criteria: * men and women from 18 to 65 years old. * body mass index (bmi) ≥25 and \<30 kg/m2. * adequate cultural level and understanding for the clinical trial. * signed informed consent exclusion criteria: * subjects with bmi ≥30 or \<25 kg /m2 * subjects diagnosed with diabetes mellitus. * subjects with dyslipidemia on pharmacological treatment * subjects with hypertension on pharmacological treatment * subjects with established diagnosis of eating disorder * smokers or those subjects with high alcohol consumption (\> 2-3 servings/ day in men and\> 1 serving/day in women (1 serving = 1 glass of wine or 1 bottle of beer) * subjects under pharmacological treatment (except oral contraceptives) * subjects with large weight fluctuations of more than 4 kg or who have undergone in six months a weight loss diet * subjects with sensory problems * subjects with gastrointestinal diseases that affect the digestion or absorption of nutrients * pregnant or breastfeeding women * women with menstrual irregularities (absence of menstrual cycle at least 2 months) * subjects with intense physical activity. * subjects with food allergies to meals included in breakfast, study product or lunch or that reject their consumption * subjects with a diagnosis of celiac disease or a gluten intolerance

Keywords: satiety vegetable protein yogurt fiber visual analogue scale cross-over
a multicenter study comparing the analgesic effects and safety of abt-639 compared to placebo in subjects with diabetic neuropathic pain

Conditions: Diabetic Neuropathic Pain

Summary: people with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.


Eligibility criteria:
inclusion criteria: * subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. * subject must have an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the baseline visit. exclusion criteria: * subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from diabetic neuropathic pain (dnp) or interfere with the pain assessments of dnp. * a subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with dnp assessments or other functions. * subject has clinically significant abnormalities in clinical laboratory tests.

Keywords: diabetic asymmetric polyneuropathy symmetric diabetic proximal motor neuropathy diabetic mononeuropathy simplex, diabetic autonomic neuropathy, diabetic amyotrophy mononeuropathy diabetic neuropathy asymmetric diabetic proximal motor neuropathy diabetic polyneuropathy painful diabetic mononeuropathy neuralgia
molecular markers in treatment in endometrial cancer

Conditions: Endometrial Neoplasms; Neoplasm Metastasis

Summary: the purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.

this is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. for the previously studied tumor markers p53, p16, er, pr and her2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. we also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. there will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of her2/neu, egfr, receptor tyrosine kinase, mtor, pten and hormone receptor pathways.

Eligibility criteria:
inclusion criteria: * women with endometrial carcinoma * available endometrial biopsy * informed consent exclusion criteria: * no informed consent

Keywords: endometrial cancer molecular markers lymph node metastasis prospective study prognosis cancer of endometrium tumor markers, biological
improving stroke prevention therapy for patients with atrial fibrillation in primary care

Conditions: Atrial Fibrillation

Summary: the objective of this project is to increase the proportion of patients with af that receive adequate stroke prevention therapy. over half of patients with af who suffer strokes are permanently disabled. yet there remains a large portion of patients who do not receive appropriate stroke prevention therapy. the investigators hypothesize that a toolkit of quality improvement strategies in primary care could increase the proportion of patients with atrial fibrillation appropriately treated with stroke prevention therapy. the investigators' goal is to ensure the toolkit of interventions can be easily incorporated into day-to-day practice in primary care and can be readily and broadly disseminated if successful.

the prevalence of atrial fibrillation (af) is growing as the population ages and 15% of all strokes are already attributed to af. unfortunately, half of patients with af do not receive prescriptions for anticoagulation to prevent stroke due to a variety of system, provider, and patient-level barriers. the investigators will conduct a pragmatic, cluster-randomized controlled trial to test a 'toolkit' of quality improvement interventions in primary care. in keeping with the recommendations of the chronic care model to simultaneously facilitate proactive care by providers and activate patients, the toolkit includes provider- focused strategies (education, audit and feedback, electronic medical record-based tools including decision support and reminders) plus patient-directed strategies (educational letters and reminders). thirty three primary care clinics will be randomized to the intervention or usual care. the trial will last 12 months and will be powered to show a difference of 10% in the primary outcome of proportion of patients receiving guideline-concordant care for stroke prevention. analysis will be blind to allocation.

Eligibility criteria:
inclusion criteria: * physicians are participants in the electronic medical record administrative-data linked database (emrald). * patients are rostered to participating physicians, with a diagnosis in the chart of atrial fibrillation exclusion criteria: * physicians who do not consent to data sharing * patients who change physicians during the course of the study
modification of rhythmic risk assessment by ventricular tachycardia ablation

Conditions: Ventricular Tachycardia

Summary: sudden cardiac death is a frequent cause of cardiovascular mortality. numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias.

sudden cardiac death is a frequent cause of cardiovascular mortality. numerous rhythmic risk assessment criterion have been described targeting the substratum, the cardiac nervous tone or the trigger of arrhythmias. development of ventricular tachycardia ablation in the past few years show interesting results preventing the recurrence of ventricular arrhythmias. rhythmic risk assessment criterions have never been studied in relation with ventricular tachycardia ablation. the purpose of this study is to explore the modifications of these criterions after ventricular tachycardia ablation.

Eligibility criteria:
inclusion criteria: * patients undergoing ventricular tachycardia, * patients with ischemic cardiomyopathy according to european society of cardiology guidelines, * patients with implanted cardiac defibrillator. exclusion criteria: * contra-indication to stress test, * permanent atrial fibrillation, * permanent ventricular pacing, * left bundle block.

Keywords: ablation sudden death signal averaged ecg t wave alternans heart rate variability
a phase i, open label dose escalation study to evaluate safety of ihivarna-01 in chronically hiv-infected patients under stable combined antiretroviral therapy

Conditions: HIV-infection

Summary: the mai purpose of the study is to evaluate the safety and to establish the recommended dose of ihivarna-01 as a new therapeutic vaccine against hiv


Eligibility criteria:
inclusion criteria: 1. patient is ≥ 18 years of age 2. voluntarily signed informed consent 3. patient is male, or female with negative pregnancy test prior to enrolment 4. patient has a proven hiv-1 infection (with positive antibodies against hiv-1 and a detectable plasma hiv-1 rna before cart) 5. patient must be on stable treatment with cart for at least 6 months (cart is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents) 6. nadir cd4+ cell counts must be above or equal to 350 cells/μl (1 or 2 occasional determinations below 350 will be allowed) 7. current cd4+ cell count must be at least 450 cells/μl 8. hiv-rna must be below 50 copies/ ml for the last 6 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 50 copies/ml are permitted) exclusion criteria: 1. treatment with a non-cart regimen of antiretroviral agents prior to the start of cart; 2. history of a cdc class c event (see appendix v); 3. patient is female and has a positive pregnancy test or the wish of pregnancy: 4. active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit; 5. therapy with immunomodulatory agents, including cytokines (e.g. il2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit; 6. use of anti-coagulant medication; 7. use of any investigational drug during the 90 days prior to study entry; 8. previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy eudract no. 2014-004591-32 33 protocol version 1.1, dated 10 february 2015 9. any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives. 10. active hepatitis c virus or hepatitis b virus co-infection 11. non-subtype b hiv infection