Kornimate/medical-research-clean huggingface dataset:
early movements as a predictor of future developmental delay

Conditions: Cerebral Palsy; Premature Birth

Summary: cerebral palsy (cp) is a major developmental problem. major risk groups of cp, are preterm infants and multiple pregnancies. previous studies using the general movements methodology demonstrated early identification of cp, as early as 3 month of age. this method was implemented mainly on preterm infants this study goal is to enlarge the scope of the methodology to infants of multiple pregnancies. a second goal is to study early motor development and its future consequences by comparing the development of the infants of the same multiple pregnancy.

cerebral palsy (cp) is a motor development problem with a prevalence of 2 per 1000 live birth. there are many etiologies to the syndrome such as: brain malformations, infections during pregnancy, pre and perinatal, anoxic brain damage etc. a high risk group for these causes is preterm infants and infants of multiple pregnancies. major motor deficits or brain insults are recognizable at early weeks but most of them are more subtle and are recognized at the age of one to two years. the general movements methodology was developed by prechtl hf is aimed to identify motor development deficits as early as 3 month. the methodology is using video recording to describe a trajectory of the development of spontaneous movements between birth and 3 month. deviation from the trajectory was highly correlated with future motor mal-development. in our work we will study the motor development of infants of multiple pregnancies. these infants are one of the risk groups to develop cp. we will use the general movements methodology to identify cp as early as possible. it will generalize its predicative power to this risk group. moreover, we will enlarge our knowledge of motor development by comparing the development of infants of the same pregnancy.

Eligibility criteria:
inclusion criteria for preterm infants: * preterm infant under 37 weeks * normal or intraventricular hemorrhage grade i at u/s examination * no neurological family history * no maternal drug use with neurological effect during pregnancy * normal prenatal history such as: no evidence of hypoxic ischemic encephalopathy * no convulsions * normal karyotype * no major congenital heart defect * dizygotic twins inclusion criteria for full term infants: * normal physiological examination * no neurological family history * no maternal drug use with neurological effect during pregnancy

Keywords: motor development multiple pregnancies general movement video recording
oral versus parenteral nutrition support to improve protein balance in colorectal surgical patients

Conditions: Colon Cancer

Summary: a prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (ppn) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. the effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.


Eligibility criteria:
inclusion criteria: 1. the american society of anesthesiologists' (asa) class 1 to 3 2. colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy) 3. nutrition status: 18.5 \ 35g/l exclusion criteria: 1. history of hepatic failure (child-pugh score a-c and transaminases outside the normal range) 2. renal impairment (serum creatinine outside normal range) 3. cardiac failure (new york heart association (nyha) classes i-iv) 4. hepatic, renal, cardiac transplant 5. endocrine disorders: diabetes type i \& ii, hyper and hypothyroidism 6. active inflammatory bowel or diverticular disease (crohn's disease, ulcerative colitis) 7. musculoskeletal or neuromuscular disease 8. anemia defined as hematocrit \< 30, hemoglobin \< 10 g/dl, albumin \< 25 mg/dl 9. previous spine surgery or scoliosis limiting use of epidural 10. pregnancy 11. use of steroids 12. milk protein allergy or intolerance

Keywords: bowel resection
treatment adherence enhancement in bipolar disorder

Conditions: Treatment Noncompliance; Bipolar Disorder

Summary: bipolar disorder (bd) is a serious and chronic mental illness that is associated with substantial impairment in quality of life and functional outcomes, high rates of suicide, and high financial costs. in spite of a proliferation of treatments for bd, nearly half of individuals with bd do not benefit from pharmacotherapy because of sub-optimal medication treatment adherence. non-adherence with bd medication treatment dramatically worsens outcomes. reasons for non-adherence among individuals with bd are multi-dimensional, and it has been suggested that adherence enhancement might work best if the intervention specifically addresses factors that are important and modifiable for a specific individual. in spite of the enormity of the problem, the literature on interventions to improve treatment adherence is surprisingly limited. there is an urgent need for interventions to enhance treatment adherence among bd patients that: 1) are at high risk for future treatment non-adherence; 2) may not have access to or interest in long-term, high-intensity, and specialized care; and 3) are flexible and patient-focused taking into account reasons for non-adherence for a specific individual. the proposed study is a first-ever rct focused specifically on bd treatment adherence enhancement, and will test whether a customized adherence enhancement (cae) psychosocial intervention improves adherence and mental health outcomes compared to broadly-directed, non-individualized education (edu). the proposed project has the potential to greatly advance the care of bd patients who are at greatest risk for poor health outcomes, with findings expected to be generalizable across a variety of treatment settings. hypothesis 1: cae will be associated with greater improvement in treatment adherence compared to broadly-directed, non-individualized bd education (edu). hypothesis 2: cae will be associated with improved bd symptoms compared to edu.


Eligibility criteria:
inclusion criteria: * subjects must have type i or type ii bipolar disorder (bd) as confirmed by the structured clinical interview for dsm-iv axis i disorders patient version (scid-p) * have had bd for at least two years duration * have received treatment with at least one evidence-based medication to stabilize mood for at least six months (lithium, anticonvulsant, or antipsychotic mood stabilizer) * either 20% or more non-adherent with current bd medication treatment (i.e. lithium, anticonvulsant, or antipsychotic mood stabilizer) exclusion criteria: * unable or unwilling to participate in psychiatric interviews. this will include individuals, who may be too psychotic to participate in interviews/rating scales * unable or unwilling to give written, informed consent to study participation * individuals at high risk for suicide who can not be safely managed in their current treatment setting
special survey for type 1 or type 2 diabetic patients

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in japan. the aim of this study is to evaluate the incidence of severe hypoglycaemia episodes under normal clinical practice for patients with type 1 or type 2 diabetes.


Eligibility criteria:
inclusion criteria: * patients with diabetes requiring insulin therapy exclusion criteria: * patients who had not been treated more than 3 months at the same investigational site * patients who had treatment history of novorapid® (insulin aspart)
preoperative nutritional assessment for predicting complications risk in patients undergoing abdominal surgery

Conditions: Abdominal Surgery

Summary: predictive value of various nutritional screening and assesment tools and a surgery scoring system (possum score) for predicting postoperative complications in patients scheduled for abdominal surgery.

preoperative malnutrition in surgical patients is an established risk factor of peri-operative morbidity and mortality, post-operative complications, infections and increased length of hospital stay. the reported prevalence of malnutrition in gastrointestinal (gi) and major abdominal surgery patients ranges from 30% to 50%. for these reasons it is important to recognize malnourished patients before surgery in order to provide the most appropriate preoperative nutritional therapy which will in turn improve nutritional status and reduce postoperative complications and length of hospital stay. the aim of the present study was to compare the prognostic power of different screening tools for post - op complications. this was a prospective observational cohort study, performed in patients scheduled for an abdominal operation in the second department of surgery, evangelismos general hospital in athens, greece. all patients were screened at admission and before operation. data were collected in a special form by the dietician and the surgeon, with the use of screening tools and the local electronic medical record system called "emrora". patients were followed up after surgery until discharge by the surgeon who recorded any complication or case of death in a new form.

Eligibility criteria:
inclusion criteria: * 18 years at least * diseases of the digestive tract (oesophageal, gastric or intestinal), or other abdominal diseases requiring elective surgery, exclusion criteria: * age \< 18 * pregnancy * major coagulopathy * permanent pacemaker * specific preoperative nutritional support before admission to hospital * unable to give consent

Keywords: nutritional assesment nutritional screening tools abdominal surgery stomach neoplasms colorectal surgery
optimal feeding tube dwell time in vlbw infants to reduce feeding tube contamination

Conditions: Infection

Summary: the study team will determine whether a decreased feeding tube dwell time will reduce feeding tube contamination

contaminated feeding tubes can occur in the neonatal intensive care unit (nicu) and have been associated with significant morbidity. due to an immature immunologic systems, premature infants are at significant risk of complications related to contaminated feeding tubes. feeding tube dwell time may affect the level of contamination. this study will determine if a maximum feeding tube dwell time of 48 hours reduces contamination compared to a maximum feeding tube dwell time of 7 days, thereby improving neonatal health outcomes.

Eligibility criteria:
inclusion criteria: * be born to a mother who is at least 18 years of age and english or spanish speaking * born at \< or equal to 30 weeks * have a birthweight \< or equal to 1500 grams * be born to a mother who is covid negative * have a feeding tube placed within 24 hours of birth * be expected to require a feeding tube for 4 weeks following birth. exclusion criteria: * infant with known congenital gi anomalies * infants which are not expected to live * infants will be withdrawn from the study if they require abdominal surgery for gi morbidities

Keywords: neonatal intensive care unit (nicu) feeding tube contamination
evaluation of the performance of self-monitoring optimized by therapeutic education in the recurrence of wet age-related macular degeneration (amd)

Conditions: Age-related Macular Degeneration

Summary: monocentric and prospective study, evaluating the benefit of self-monitoring optimized by therapeutic education either by the environmental amsler or the amsler grid according to the patient's choice and to determine the patient's ability to determine the reality itself recidivism and therefore the need for treatment.


Eligibility criteria:
inclusion criteria: * affiliation to a social security scheme * patient agreeing to participate in the process of therapeutic education. * centrofoveal fixation with visual acuity\> 2/10 * antecedent of at least one recurrence so that the patient is aware of the notion of recurrent chronic disease * intravitreal injection antecedent less than 6 months ago exclusion criteria: * vulnerable people * majors subject to legal protection or unable to express their consent * arterial emboli disorders of less than three months such as myocardial infarction, stroke
streptococcus pneumonia: effects of pcv13 on pneumococcal carriage

Conditions: Nasopharyngeal Carriage of S. Pneumoniae

Summary: the specific aim is to evaluate the impact of pcv13 as administered in the pediatric primary care clinic at boston medical center on the serotype specific carriage of streptococcus pneumoniae in children \< 5. specifically the investigators will measure the decline in vaccine serotypes, the proportion of children receiving vaccine required to achieve 50% reduction in serotype specific carriage and the correlation between immunogenicity of the specific serotypes and decline in carriage. the study has been extended to complete 5 years of surveillance to determine the new sp serotype distribution at the time presumably a new equilibrium has been achieved.


Eligibility criteria:
inclusion criteria: * children \< 5 years of age receiving care at primary care center at bmc and as many parent(s) as willing to participate exclusion criteria: * children with facial malformations making np sampling unacceptable * children in foster care

Keywords: pneumococcal vaccine nasopharyngeal carriage
adujvant ct+crt vs adujvant ct after d2 resection for locally advanced proximal gastric adenocarcinoma

Conditions: Gastric Adenocarcinoma

Summary: this study evaluates the addition of adjuvant chemoradiotherapy to adjuvant chemotherapy in the treatment of locally advanced proximal gastric adenocarcinoma after standard d2 radical resection.

because of its special anatomical structure, local recurrence rate of locally advanced proximal gastric adenocarcinoma is still high after radical operation. as a local/regional therapy, radiotherapy combined with concurrent chemotherapy can kill local residual tumor cells and reduce the risk of local and regional recurrence.

Eligibility criteria:
inclusion criteria: * voluntary participation and written signature of informed consent. * age 18-70, gender unlimited. * gross pathology confirmed that the tumor center was within 1 cm to 5 cm of the egj line. histopathologically diagnosed as adenocarcinoma. * no neoadjuvant therapy. * transabdominal standard d2 radical operation was performed and r0 resection was performed. ascites cytology was negative. * the pathological stages were iib, iiia, iiib and iiic. * there was no intraperitoneal implantation and distant metastasis. ct should be routinely performed to evaluate the tumor bed before radiotherapy. positron emission tomography (pet-ct) could be accepted to determine whether there was residual or distant metastasis. * physical condition score ecog 0-1. * no history of serious heart and lung diseases, abnormal hematological examination and immunodeficiency: hemoglobin (hb) \> 9 g/dl; white blood cell (wbc) \> 3 x 109/l; neutrophil (anc) \> 1.5 x 109/l; platelet (pt) \> 100 x 109/l; bilirubin \< 1.5 times the upper limit of normal value; glutathione transaminase (alt) \& alanine transaminase (ast) = 2.5 times the upper limit of normal value; serum creatinine \< 1.5 times the normal value upper limit. * no other systemic tumors were found. * fertile men or women are willing to take contraceptive measures in the trial. * the daily energy intake is more than 1500 kcal. exclusion criteria: * those who had a history of malignant tumors (except skin basal cell carcinoma, thyroid papillary adenocarcinoma and cervical carcinoma in situ, who survived for more than 3 years after treatment). * patients with a history of neoadjuvant radiotherapy and chemotherapy before operation. * study participants who participated in other clinical trials within 30 days before treatment. * pregnancy, lactation or fertility without contraceptive measures. * drug addiction and other adverse drug addiction, long-term alcoholism and aids patients. * those with uncontrollable infections, seizures, or loss of self-awareness due to mental illness. * those with a history of severe allergy or specific constitution. * researchers believe that it is not appropriate to participate in this experiment.

Keywords: gastric adenocarcinoma adjuvant radiotherapy
alteration of the immune response in bacterial infection

Conditions: Infection

Summary: the pilot study "ariibo" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. this study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects. in terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. one of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile. it is important to compare the data collected in obese patients infected (first study called "ariibo"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ariibact"


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * bmi 18 to 25 * presence of a bacterial infection * pneumopathy (documented or probable) * acute pyelonephritis / prostatitis * skin and soft tissue infection (erysipelas, fasciitis, excluding pressure ulcers) * cholecystitis / cholangitis, * surgical site infection * signed informed consent exclusion criteria: * patients with documented viral, parasitic or mycotic infections * patients with bacterial infection\> 4 weeks (eg endocarditis, osteoarticular infections) * patients followed in intensive unit care * patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years * patients with systemic diseases (connective tissue diseases, vasculitis) * known immunodepression syndrome (cvid, hiv ...) * immunosuppressive therapy in progress until less than one month before inclusion (corticosteroids, dmards, biotherapies, hydroxychloroquine)
safety and efficacy of the cochlear nucleus ci422 cochlear implant in adults

Conditions: Hearing Loss

Summary: clinical study to evaluate the safety and efficacy of the cochlear™ nucleus® ci422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.


Eligibility criteria:
inclusion criteria: 1. eighteen years of age or older at the time of implantation 2. moderate low frequency thresholds up to and including 1000 hz, severe to profound high frequency (above 3000 hz) sensorineural hearing loss 3. minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized national acoustics laboratory (nal) fitting method described in the fitting and use of hearing aids section below 4. aided consonant nucleus consonant (cnc) word recognition score (mean of two lists) between 10% and 50%, inclusive in the ear to be implanted 5. aided cnc word recognition score (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 70% 6. willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation 7. english spoken as a primary language exclusion criteria: 1. duration of severe-to-profound hearing loss greater than 30 years 2. congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age) 3. medical or psychological conditions that contraindicate undergoing surgery as determined by the investigator 4. ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array 5. conductive overlay of 15 decibels (db) or greater at two or more frequencies, in the range 500 to 1000 hz 6. deafness due to lesions of the acoustic nerve or central auditory pathway 7. absence of cochlear development 8. diagnosis of auditory neuropathy 9. active middle-ear infection 10. tympanic membrane perforation in the presence of active middle ear disease 11. unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the investigator 12. unwillingness or inability of the candidate to comply with all investigational requirements as determined by the investigator 13. additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the investigator
contraceptive practices and cervical screening in women with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: little is known about gynaecological follow-up and cervical screening in cystic fibrosis (cf). only few studies have described contraceptive practices in cohorts of cf women. the investigators did a cross-sectional study in a cohort of 155 cf women attending the lyon adult centre. women attending the cf adult centre in 2014 completed a written questionnaire about their contraceptive choices, frequency of gynaecological follow-up and cervical screening. other clinical data were collected from the cf adult centre registry. one hundred and twenty women (100%) answered the questionnaire, among whom two were post-menopausal (46 and 59 years of age), and five were pregnant. seventy-four per cent of the women declared they had undergone gynaecological followup (89% of the women with transplantation), and only 55% reported having at least one previous pap smear test. among the transplanted patients, only 58% had had a papsmear test, despite immunosuppressive treatment. the overall rate of contraception was only 64% and in diabetic women, it was 61%. among contraception users; 65% used oral contraception, predominantly combined estrogen-progestagen (47%); among diabetic patients, 26% used progestin-only contraception. intrauterine device accounted for 10% of patients using contraception, and tubal ligation only 4%. this study is limited by its cross-sectional design. despite an internal validation of the questionnaire showing an almost perfect agreement, the risk of recall bias has to be taken into account. this study of practices highlights the importance of improved information regarding sexuality, fertility and reproductive health in young women with cf. a regular gynaecological follow-up and cervical screening is mandatory in this population. better gynaecological care and contraceptive advice would help to avoid unplanned pregnancies, and optimize contraceptive selection in relationship to specific clinical conditions.


Eligibility criteria:
inclusion criteria: * woman with cystic fibrosis * followed in the lyon adult centre in 2014 exclusion criteria: - no exclusion criteria

Keywords: cystic fibrosis contraception gynaecological follow-up screening pap smear counselling