Kornimate/medical-research-clean huggingface dataset:
longterm outcome of children with neonatal intra-ventricular or intra-cranial hemorrhage

Conditions: Neonates Premature

Summary: intraventricular hemorrhage (ivh) is the most commonly recognized cerebral lesion on ultrasound in extremely preterm infants. papile classification is commonly used to grade the severity of ivh. grade iii-iv ivh and other lesions noted on ultrasound including periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well documented to be associated with adverse neurodevelopmental outcomes. however, the true impact of lower-grade ivh on the neurodevelopment of these extreme preterm infants has not been well described. also neurodevelopmental outcome for neonatal non-traumatic intra cranial hemorrhage (ich) is not well established. the aim of this study is to look retrospectively at babies with neonatal ivh or ich and follow their radiological, cognitive, motor and functional outcomes. the study will focus on postnatal files, and on images performed as part of the child's follow-up during hospitalization and after discharge.

the study will be performed as a retrospective chart review with key words : ivh, ich of babies discharged from laniado hospital neonatal care service or icu, or being followed in the pediatric neurosurgical clinic and prematurity/neonatology clinic of the hospital. all charts of such children will be included, to review clinical, and radiological available data. registration of clinical, radiological data as presented or submitted by the parents on neurosurgical neonatology and neurological followups will be performed by pi or ci and coded in the data anonymously. follow up will be performed as clinically indicated without addition of any specific studies due to the research. the endpoints of the study: primary endpoint: 1. how many children needed surgical intervention related to the hemorrhage (ich, ivh) secondary endpoints: 2. clinical and functional outcome of children - regarding normal schooling, need for assistance in adl in difference from the parallel normal child. correlation between the type of hemorrhage, clinical data related to gestational age and weight at birth, and outcomes will be performed.

Eligibility criteria:
inclusion criteria: newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage children who are followed by pi in the neurosurgical clinic in laniado hospital and suffered from ich or ivh and were treated elsewhere after birth - exclusion criteria: loss to followup within the first year after birth -
analysis of de-identified data from commercially-available app lose it!

Conditions: Overweight and Obesity

Summary: the study team analyzed de-identified user data provided by the commercial app lose it!, an entity of fitnow, inc.

the study team analyzed de-identified user data collected by lose it! for the purposes of investigating behavioral aspects of weight loss and maintenance, including engagement with the platform; user-reported data on diet, exercise, and other behaviors; data generated by lose it! describing macronutrient or total calorie intake; periodicity of weight-related actions; user-reported demographic information; and any data from linked applications within lose it!. all data was anonymized and exchanged as limited data sets.

Eligibility criteria:
inclusion criteria: - new app users located in the u.s. and canada, between 18 and 80 years of age, that are overweight (25 \ 30), who actively used the app each month from january to may of 2016, defined as users who logged food at least 8 times during the first or second half of each month (january, february, march, april and may). exclusion criteria: -

Keywords: app weight loss diet behavior
mifepristone versus osmotic dilators in conjunction with misoprostol for cervical preparation prior to d&e at 14-19 weeks

Conditions: Legally Induced Abortion Without Mention of Complication

Summary: dilation and evacuation (d\&e) is a common surgical procedure in the u.s. adequate pre-operative preparation of the uterine cervix is an important part of preventing complications of the procedure. traditionally, the uterine cervix is prepared for the procedure using water-attracting dilators, which are placed via a speculum exam and cause discomfort for many women. the objective of this study is to investigate the comparative effectiveness of mifepristone (an oral tablet) versus dilators for cervical preparation for d\&e.


Eligibility criteria:
inclusion criteria: * \>18 years old * viable, singleton pregnancy * voluntarily seeking abortion between 14-19 weeks gestation * able to give informed consent and comply with study protocol * fluent in english or spanish exclusion criteria: * allergy to study drugs

Keywords: induced abortion mifepristone dilation and evacuation cervical preparation osmotic dilators misoprostol
the time-dependent development of incisional hernias in emergency laparotomy incisions of high-risk patients

Conditions: Incisional Hernia; Emergency Midline Laparotomy

Summary: the aim of this study is to describe the development of symptomatic and asymptomatic incisional hernias after emergency midline laparotomy over time in high-risk patients evaluated by consecutive mri-scans.

all patients operated with an emergency midline laparotomy in our clinic are potential participants and will be screened for participation. potential participants will be briefly informed about the project by the hospital staff. if the patients are interested, they will be thoroughly informed about the study and asked to participate by one of the trial investigators before discharge. data will be obtained from the participants hospital files and by patient survey/interview. all data will be entered into a database using redcap by trial investigators or their delegates. enrolled patients will be followed for two years. the trial involves four consecutive mri-scans one month, three months, six months and two years after surgery. change in quality of life, physical functioning and pain-score are also obtained by patient survey/interview at each visit. a concluding physical examination and abdominal wall ultrasound examination will be performed two years after the surgery.

Eligibility criteria:
inclusion criteria: * unscheduled midline laparotomy in an emergency or subacute setting, involving perforated bowel, bowel obstruction, bowel ischemia (due to mesenteric vascular disease or incarceration), inflammatory diseases (e.g. diverticulitis, appendicitis, ulcerative colitis, cholecystitis and crohn's disease), abscesses, non-traumatic intraabdominal bleeding or any emergency re-operation to elective surgery * age of 18 years or above * bmi above 27 * at least one risk factor for incisional hernia i.e. earlier midline laparotomy, bmi \> 30, abdominal aortic aneurysm or prior surgery for abdominal aortic aneurysm, active smoking, liver cirrhosis, re-laparotomy, age \> 75, history of primary ventral hernia (treated or untreated before index surgery), large laparotomy involving more than 2/3 of the abdominal wall as measured from the xiphoid process to the pubic bone exclusion criteria: * malign, incurable disease * other reasons for short life expectancy \<2 year as evaluated by the investigator * midline-incisions \<15 cm * mesh augmentation of abdominal wall closure at index surgery or earlier mesh augmentation of the abdominal wall * severe claustrophobia or any other mental habitus, making it impossible to perform mri-scan without sedation * metallic magnetic implants that serves as a contraindication for mri-scan (including pacemakers, large tattoos, insulin pumps, etc.) * metallic prosthetic non-magnetic implants that are suspected to create severe artefacts on the mri-scan of the abdominal wall
cochlear response telemetry and hearing preservation

Conditions: Hearing Impairment, Sensorineural

Summary: the main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant. the cochlear response telemetry tool aims to measure the response from the cells within the cochlea and may be useful in the future to help to improve the surgical technique and potentially help surgeons better preserve any natural hearing that is available. the measurements are obtained using the cochlear implant and sound processor while a sound is presented to the ear through an earphone (like an earplug) placed into the ear canal.


Eligibility criteria:
inclusion criteria: * candidate for cochlear implantation (with ci522, ci532, ci622, ci632 or hybrid-l24 (us only) according to local indications * 18 years of age or older at the time of enrolment * pre-operative audiometric threshold in the implanted ear at 500 hz of better than or equal to 80 db hl * willingness to participate in and to comply with all requirements of the protocol exclusion criteria: * prior cochlear implantation in the ear to be implanted * ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array * abnormal cochlear/nerve anatomy on pre-operative ct or mri imaging (excluding a mild mondini malformation or large vestibular aqueduct syndrome) * deafness due to lesions of the acoustic nerve or central auditory pathway * diagnosis of auditory neuropathy * active middle-ear infection * additional handicaps that would prevent participation in evaluations * unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Keywords: cochlear implantation, electrocochleography
safety, reactogenicity and immunogenicity of an h5n1 vlp

Conditions: Pandemic Influenza

Summary: this is a phase i/iia randomized, double-blind, placebo-controlled study to evaluate the safety, reactogenicity, and immunogenicity of 3 potencies (dosages) of h5n1 vlp vaccine or placebo in healthy adults 18 to 40 years of age.


Eligibility criteria:
inclusion criteria: 1. male or female 18 to 40 years of age at the time of the vaccination. 2. subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., return for follow-up visits and completion of the data collection tool). 3. available by telephone. 4. free of obvious health problems as established by medical history and clinical examination before entering the study. 5. if subject is of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 30 days prior to vaccination. she must also have a negative pregnancy test at study entry and must agree to continue such precautions for two months after completion of vaccination. 6. must provide written, informed consent. exclusion criteria: 1. use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period. 2. has received any other licensed vaccines within 4 weeks prior to enrollment in this study. 3. has received any influenza vaccine within the prior 12 month period. 4. has received any investigational vaccine designed for protection against avian influenza. 5. chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine. the use of inhaled and nasal steroids will be permitted. 6. any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination. 7. administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or during the study. 8. acute disease at the time of enrollment. acute disease is defined as the presence of a moderate or severe illness with or without fever ≥ 100.5º f. 9. acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. 10. major congenital defects or serious chronic illness. 11. history of any neurological disorders or seizures, with the exception of febrile seizures during childhood.
visual outcomes after extended depth of focus intraocular lens implantation with and without digital assistance

Conditions: Presbyopia; Pseudophakia; Cataract; Refractive Errors

Summary: the primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

this is a prospective, comparative study of 60 patients diagnosed with grade 2 cataracts (according to locs iii) that underwent one of the following surgical procedures: insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance. in these patients, a comparison of postoperative visual acuity curves of both groups will be conducted. visual acuity curves will be designed using the validated digital optotype democritus digital acuity \& reading test (ddart). assessment of visual acuity will be performed at 9 different distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity. additionally, the degree of subjective satisfaction of the patient will be evaluated through an interview (nei-vfq 25). all examinations will be conducted according to standard clinical practice.

Eligibility criteria:
inclusion criteria: * diagnosis of grade 2 cataracts (according to locs iii) * age \>45 years. exclusion criteria: * inability to understand the greek language and respond to the interview * conditions of the posterior or corneal segment * glaucoma * previous intraocular surgery

Keywords: pseudophakic presbyopic correction extended depth of field intraocular lenses visual curve visual acuity
autologous bone marrow-derived mesenchymal stem cells for atrophic endometrium in patients with repeated ivf failures

Conditions: Infertility, Female; Infertility of Uterine Origin; Asherman Syndrome

Summary: investigators will examine safety and efficiency of the cell product of autologous bone marrow-derived mesenchymal stem cells (msc) for patients with repeated ivf failures and hypoplastic or/and fibrosis process of endometrium

sixty patients eligible for the study will be divided to two groups (experimental and control) according to randomization (envelope) procedure in 1:1 ratio. for patients of the main group bone marrow stem cells will be extracted from the crest of the ilium using standard methodology. after extraction and cultivation final product of autologous bone marrow-derived mesenchymal stem cells will be transplanted to endometrial cavity on menstrual cycle day 5-6. meanwhile patients will receive three cycles of hormonal replacement therapy (4 mg progynova (bayer pharma, germany) daily on menstrual cycle day 5-25 in combination with 20 mg duphaston (abbott healthcare products, b.v., netherlands) daily from day 15 to day 25. on day 20 of hormonal replacement therapy (hrt) of the last (third) cycle pipelle-biopsy of endometrium will be performed. obtained material will be analyzed by immunohistochemistry with the assessment of estrogen and progesterone receptors, vegfa, gm-csf, cd133+, cd34 and cd56. ultrasound characteristics of endometrial quality will be registered on day 9-10 and day 19-21 of every cycle. when morphological and echographic parameters of endometrium are found satisfactory for embryo transfer, the hrt for endometrial preparation for frozen/thawed embryo transfer cycle will be initiated. if acceptable endometrial characteristics are not achieved, patients could be offered to undergo repeated (not more than 3) transplantation of msc procedures. control group will receive three standard cycles of hrt following hysteroscopy before frozen/thawed embryo transfer. if endometrial characteristics are found unsatisfactory, gestational surrogacy might be offered.

Eligibility criteria:
inclusion criteria: * repeated ivf attempts with high and good quality embryo transfer in fresh and frozen ivf cycles; * age 20-44 years; * endometrial thickness less than 6 mm in 2 or more of hrt cycles for endometrial preparation for embryo transfer * hysteroscopic evidence of fibrosis processes of uterine cavity with the absence of positive dynamics of hrt in 3 months following operation; * signed informed consent. exclusion criteria: * contraindication for pregnancy; * absence of cryopreserved embryos, stored at clinic's cryobank; * bmi \> 30 kg/m2; * impaired carbohydrate metabolism according to glucose tolerance test; * thrombosis in anamnesis; * oncological diseases in anamnesis; * diagnosed inherited thrombophilia; * uterine fibroids of more than 4 cm or more than 2 fibroids of 2.5 cm diameter; * nodal form of adenomiosis; * ovarian cysts more than 4 cm in diameter.

Keywords: repeated ivf failure stem cell
twin trial of pde4 inhibition with roflumilast for the management of plaque psoriasis

Conditions: Chronic Plaque Psoriasis

Summary: this study will assess the safety and efficacy of arq-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

this is a parallel group, double blind, vehicle-controlled study in which arq-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis

Eligibility criteria:
inclusion criteria: * participants legally competent to sign and give informed consented and if appropriate assent as required by local laws * males and females ages 2 years and older (inclusive) * clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the investigator * females of childbearing potential (focbp) must have a negative pregnancy test at screening (visit 1) and baseline (visit 2). in addition, sexually active focbp must agree to use at least one form of highly effective contraception throughout the trial. * in good health as judged by the investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis. * subjects considered reliable and capable of adhering to the protocol and visit schedule, according to the judgment of the investigator. exclusion criteria: * planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other led. * females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. * previous treatment with arq-151 or its active ingredient * subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the investigator. * subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product * subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the investigator's opinion, makes them unsuitable for clinical study participation
observations from long term responders in the gefitinib (iressa) expanded access program (eap)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of the study is to determine patient characteristics from patients that have used iressa for a period of minimal 3 years.


Eligibility criteria:
inclusion criteria: * participation in the gefitinib expanded access program * patient still uses gefitinib in september 2009

Keywords: nsclc egfr gefitinib observational
prevention of early postmenopausal bone loss with lactobacillus reuteri

Conditions: Postmenopausal Osteoporosis

Summary: this study evaluates the effect of two different doses of lactobacillus reuteri atcc pta 6475 (l.reuteri 6475) on bone loss in early postmenopausal women. one third of the participants will be randomised to the lower dose, one third to the higher dose and one third to placebo.

we have previously shown that daily supplementation of the probiotic lactobacillus reuteri atcc pta 6475 (10e10 colony-forming units (cfu)) was able to reduce bone loss over 12 months in 76-year-old women compared to placebo. it is not known if the probiotic is effective over longer time periods or if the effect is dose-dependent. the aim of this study is to investigate if two different doses of lactobacillus reuteri atcc pta 6475 (total daily dose of either 1x10e9 or 1x10e10 cfu/day) can prevent or reduce bone loss, compared to placebo, in early (1-4 years since last menses) postmenopausal women over 24 months. all women will receive 400 iu of vitamin d (cholecalciferol) per day. changes in bone mineral density, bone geometry and microstructure will be measured using dual x-ray absorptiometry and high resolution peripheral computed tomography.

Eligibility criteria:
inclusion criteria: * postmenopausal women, 45 years or older, within 1-4 years from their last menses. * vitamin d levels above 25 nmol/l. * signed informed consent. * stated availability throughout the entire study period. * ability to understand study instructions and willingness to adhere to the protocol. exclusion criteria: * bone mineral density of \< -2.5 combined with a fracture risk assessment tool (frax) score of 20% or higher for major osteoporotic fracture. * severe osteoporosis, defined as bone mineral density of \< -3.0 in either the total hip, femur neck or lumbar spine l1-l4. * vertebral fracture (grade ii or iii) diagnosed using lateral spine imaging with dxa. * untreated hyperthyroidism or hyperthyroidism within the last 5 years. * known untreated hyperparathyroidism. * rheumatoid arthritis. * diagnosed with disease causing secondary osteoporosis, including chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes mellitus. * recently diagnosed malignancy (within the last 5 years). * oral corticosteroid use. * previous (within the last 5 years) use of antiresorptive therapy, including systemic hormone therapy (estrogen), bisphosphonates, strontium ranelate or denosumab. * systemic skeletal disease (including e.g. paget's disease and osteogenesis imperfecta). * any systemic disease that could affect bone loss, as judged by the investigator. * use of teriparatide (current or during the last 3 years). * participation in other clinical trials. * current antibiotics treatment or within the last 2 months prior to inclusion. * current and within the past 2 months use of probiotic supplement * vitamin d deficiency (25-oh vitamin d\<25 nmol/l) * hypo- or hypercalcemia. * osteosynthesis materials in both lower legs (tibia).