Kornimate/medical-research-clean huggingface dataset:
noninvasive diagnostic platform for liver fibrosis and portal hypertension

Conditions: Liver Fibrosis; Cirrhosis; Portal Hypertension

Summary: this study is to establish a noninvasive diagnostic platform based on hemodynamic information for the assessment of liver fibrosis, liver cirrhosis and portal hypertension.

as the hemodynamics of liver vessels depend on the liver tissue mechanics, we hypothesize that the hemodynamics measurements of the liver are strongly correlated with the stages of liver fibrosis and portal hypertension, and can therefore serve as an alternative means of diagnosis. we have developed a physics-based mathematical model that incorporates our biological understanding of fibrosis development. the model quantitatively predicts changes of liver tissue stiffness and blood flow dynamics as a function of fibrosis stage. preliminary data using ultrasound doppler images and needle biopsy from liver fibrosis patients have suggested the 'prove of principle. we propose further test our hypothesis by collecting and analyzing ultrasound doppler and biopsy data to confirm the correlation between blood flow dynamics and disease stage from patients with hepatic fibrosis and portal hypertension. if tested true, we can expect to use features of ultrasound doppler as a non-invasive means of diagnosis for fibrosis and portal hypertension.

Eligibility criteria:
inclusion criteria: * inpatients who undergo liver biopsy or hepatic venous pressure gradient test exclusion criteria: * decompensated liver diseases (including ascites, variceal bleeding or hepatic encephalopathy); * alpha-fetoprotein \>100 ng/ml or serum creatinine \>1.5 × upper limit of normal (uln); * any malignant tumor; * any complications of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; * severe neurological or psychological disease; * pregnant or lactating women.

Keywords: noninvasive hemodynamics
patients at risk for sensory screening (hparss) to enhance sensory deficit screening in childhood cancer survivors

Conditions: Childhood Cancer

Summary: the overall goal of this study is to attempt to overcome the organizational barriers that impede prompt screening for at-risk sensory deficits in childhood cancer survivors (ccs). using a cross sectional design study, collaborators in the informatics research branch of the institute of informatics at the washington university school of medicine will identify ccs at risk for sensory deficits based upon their therapy exposure to generate the highlighting patients at risk for sensory screening (hparss) document. the investigators will utilize the hparss that will link therapy related risks for sensory deficits to specific screening procedures prompting the primary oncology provider to implement screening, diagnostic testing, and therapy.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of pediatric cancer (diagnosis at \<18 years of age) * treatment including chemotherapy and/or radiation therapy * completion of all cancer therapy for at least 6 months and less than 2 years * followed in the division of pediatric hematology/oncology program at the washington university school of medicine * current age between 7 and 17 years of age (age where all of the screening tests are both valid and have been successfully performed by our group) * english speaking exclusion criteria: * undergoing active cancer treatment * patient under the care of the late effects program at st. louis children's hospital * received previous diagnostic testing or rehabilitative therapy for a secondary deficit eligible for screening. * parents and/or patient illiteracy * no contact with treatment team in the past two years * in foster care or without a legal guardian

Keywords: childhood cancer survivors electronic medical record sensory deficit screening hearing loss peripheral neuropathy vestibular vision
comparison of on demand sedation with study method versus on demand sedation with conventional method for performing colonoscopy for colorectal cancer screening and surveillance

Conditions: Colorectal Cancer Screening

Summary: hypothesis 1. study method achieves lower requirement for medications 2. study method increases overall cecal intubation with comparable assessment of current experience and patient willingness to repeat future colonoscopy compared with conventional colonoscopy 3. study method results in reduction in medication-related (cardiorespiratory) complications, faster turn around of patients, compared with conventional colonoscopy 4. study method improves bowel preparation and increases polyp pickup rate colorectal cancer (crc) screening for the high and the low risk healthy asymptomatic va patients is being promoted (vha directive). compliance with this directive will result in an increased number of va patients undergoing colonoscopy. the demand for colonoscopy far exceeds the capacity available to perform the procedure in the va system. the conventional practice for colonoscopy at va facilities across the country is to perform colonoscopy under conscious sedation with air insufflation. efficiency is governed by the fact that sedated patients require time and space for recovery and these are major limiting factors in the current setting for the use of colonoscopy for crc screening. methods that maintain a high success rate and good patient assessment improve overall compliance for surveillance colonoscopy. our preliminary experience showed that patients are able to complete successful colonoscopy without sedation in 52% of cases when colonoscopy was aided by a water infusion in lieu of air insufflation method. in this group of patients, the shortened recovery time means a quick turn around of patient and a more efficient endoscopy service. patients are able to communicate better with the staff and physician regarding their problem and discharge instructions, and not subjected to the amnesic effect of sedation. next day follow-up of patient by telephone contact which requires commitment of staff time can be obviated. if this randomized study confirms the success of our preliminary findings and this technique is adopted by more endoscopists, a larger number of va patients may benefit from less sedation complications and at the same time allow for more efficient colonoscopy screening services.


Eligibility criteria:
inclusion criteria: * adult (\> 50 years old), male and female patients * scheduled and consented for screening or surveillance colonoscopy * accept randomization to the study or the conventional method * agree to complete study questionnaires will be considered for enrollment * normal healthy patients or patients with mild systemic disease, asa 1 or asa 2 exclusion criteria: * patients who decline to participate, are unable to give informed consent or to complete the questionnaires due to language or other difficulties will be excluded. excluded patients will be managed by usual procedures at the sacramento vamc

Keywords: water infusion air insufflation colonoscopy colorectal cancer screening
toric intraocular lenses for cataract patients in the nhs

Conditions: Cataract; Astigmatism; Cornea

Summary: to assess visual performance, refractive outcome, and patient satisfaction with the use of "off the shelf" toric lenses, with a set cylindrical correction of 2.00 or 4.00 diopters, and combined limbal relaxing incisions and/or off-axis intraocular lens rotation, compared to fully targeted toric intraocular lens correction.

the aim of this study is to evaluate a simplified, more cost-effective procedure for the use of toric intraocular lenses, with a focus on suitability for nhs cataract surgery. this study will involve the use of standard, "off-the-shelf" toric lenses rather than having them specifically tailored and ordered for each individual patient. eligible participants (\>1.25 d of corneal astigmatism) will be randomised, receiving a toric iol with either a 2.00 or 4.00 diopter (d) correction, depending on the degree of pre-operative astigmatism, or a toric iol individually tailored to and ordered for each patients' precise degree of corneal astigmatism. with the "off the shelf" toric iol group the correction of the astigmatic refractive error will be refined with the use of adjunctive limbal relaxing incisions lris and/or off axis rotation of the toric iol (based on a standardized protocol) so the full amount of corneal astigmatism can be targeted for correction for each patient. the clinical outcome will then be measured and compared between the 2 groups. independent safety monitoring will be performed.

Eligibility criteria:
inclusion criteria: 1. bilateral or unilateral cataracts requiring surgical intervention 2. age over 18 years 3. able to understand informed consent and the objectives of the trial 4. not pregnant, not breast feeding 5. no previous eye surgery 6. corneal astigmatism greater than 1.5 diopters in one eye. exclusion criteria: 1. age-related macula degeneration 2. glaucoma 3. previous retinal vascular disorders 4. previous retinal detachment or tear 5. any neuro-ophthalmological condition 6. any inherited retinal disorder or pathology 7. previous strabismus surgery or record of amblyopia 8. previous tia, cva or other vaso-occlusive disease 9. already enrolled in another study
safety and efficacy of s-8184 in second line treatment of stage iii or iv ovarian cancer

Conditions: Ovarian Cancer

Summary: phase iia, multicenter, dose escalation study evaluating the safety and efficacy of weekly s-8184 paclitaxel injectable emulsion in second line treatment of patients with stage iii or iv platinum resistant ovarian cancer or primary peritoneal carcinoma.

the goals of this study are to determine the objective response rate, to determine time to disease progression, duration of response, and survival, and to identify the maximum tolerated weekly dose and principal toxicities of s-8184 in this patient population.

Eligibility criteria:
inclusion criteria: histologic diagnosis of ovarian cancer or primary peritoneal carcinoma stage iii or iv disease one and only one prior cytotoxic chemotherapy regimen which must have included a platinum agent platinum resistant disease, defined as documented progression within six months of completion of first line therapy adult (18 years of age or older) patients adequate hematologic function (anc greater than 1500 cells/mm3 and platelets greater than 100,000/mm3) serum creatinine less than 2.0 mg/dl total bilirubin less than 1.5 mg/dl; sgot and sgpt less than 3 times the upper limit of institutional normal values ecog performance status of 0 - 2 bidimensional measurable or clinically evaluable disease patients who have signed an irb / ethics committee approved informed consent life expectancy at least 12 weeks patient has fully recovered from any previous surgery (at least 4 weeks since major surgery) patient has a negative pregnancy test prior to study entry if premenopausal. (patients of child bearing potential must use a medically effective form of contraception during the treatment.) exclusion criteria: patients who have received any taxane-containing preparation including taxol (paclitaxel) or taxotere (docetaxel) females who are pregnant or lactating patients with peripheral neuropathy nci-ctc grade 2 or greater patients who have received wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of study entry; or mitomycin or nitrosoureas within 6 weeks of study entry patients who have had an investigational agent within 4 weeks of study entry patients receiving concurrent anticonvulsants known to induce p450 isoenzymes
evaluation of the risk of nsf following multihance injection in patients with chronic kidney disease

Conditions: Renal Insufficiency

Summary: the objective of this long-term study is to prospectively compare the incidence of nsf in two cohorts (cohort 1 - patients with moderate chronic kidney disease egfr 30 to 59 and cohort 2 - patients with severe chronic kidney disease or kidney failure egfr \<30).


Eligibility criteria:
inclusion criteria: cohort 1 * is going to receive or has received multihance injection during an mri examination; * has ckd with egfr stably comprised between 30 and 59 ml/min/1.73m2, as calculated from a scr value obtained from the local laboratory within 24 hours prior to the multihance injection. * provides written informed consent and is willing to comply with protocol requirements. or cohort 2 * is going to receive or has received multihance injection during an mri examination; * has ckd with egfr below 30 ml/min/1.73m2, as calculated from a scr value obtained from the local laboratory within 24 hours prior to the multihance injection. * provides written informed consent and is willing to comply with protocol requirements. exclusion criteria: cohort 1 * has received a gbca within the past 12 months prior to inclusion in this study; * has unstable kidney function; * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives; * has ever been suspected of, or diagnosed with, nsf prior to the study-specific mri; * is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of nsf be suspected. or cohort 2 * has received a gbca within the past 12 months prior to inclusion in this study; * has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data and achieving study objectives; * has ever been suspected of, or diagnosed with, nsf prior to the study-specific mri; * is unable or unwilling to return for necessary office visits, to be examined by dermatologists or to undergo deep skin biopsy should development of nsf be suspected.
does melatonin restore sleep architecture in autistic children

Conditions: Sleep Disorders

Summary: although behavioral disorders origins in autistic children are still unclear, they seem to be influenced by sleep disorders. results of studies performed on sleep quality in autistic children showed a high prevalence of sleep disorders in these children, estimated between 50 and 80% compared to children with typical development and insomnia is one of the sleep disorders most frequently reported by autistic children's parents. others studies showed circadian rhythm disorder in autistic children which could be the consequence of genetic abnormalities in the melatonin synthesis and the melatonin role in the synaptic transmission modulation. melatonin by its sedative effects and its action on circadian pacemaker is a promoter of sleep proposed for insomnia treatment and circadian rhythm disorders. two major recent studies (not yet published) in the united states and in england seek to show the effectiveness of melatonin by testing the effects of three doses of melatonin on reducing sleep disorders. it is therefore interesting and important to conduct a parallel study to assess the melatonin effect not only on the reduction of sleep disorders (sleep onset latency, total sleep time...), but on sleep quality (number of nocturnal awakenings). the strength of this study lies in the combination of several measurement tools to assess the melatonin dose-effect on all parameters in both physiological (actimetrics, polysomnography), biological (dosage 24h sulfatoxymelatonin), behavioral (sleep questionnaire, index of insomnia severity, rating scale autistic disorder) as well as possible side effects. the primary objective is to determine the most effective dose of melatonin to improve sleep quality in autistic children.


Eligibility criteria:
inclusion criteria: * boys and girls from 3 to 12 years old with autism spectrum, * diagnosed by psychiatrists according to the diagnostic criteria for autism icd-10 and adi or ados positive, * with trouble sleeping, assessed by questionnaire chsq, * having made a night polysomnography, * written informed consent (signed by parents), * affiliated with the french universal healthcare system. exclusion criteria: * children who stopped all treatment for sleep for less than one month, * liver or kidney insufficiencies, * acute illness during or occurred in the month preceding the study, * neurological disease without autism spectrum , patients with non-controlled epilepsy * health background witch can influence sleep (other than autism itself), * obstructive syndrome (history - oral breathing in wakefulness, nocturnal snoring significant (heard the door closed), nocturnal respiratory effort, apnea reported by parents- and clinical examination (chronic nasal congestion, large tonsils and touching), * known hypersensitivity to the active substance or to one of the excipient contained in the verum or in the placebo, * children under treatment against-indicated with the study treatment witch can't be stopped

Keywords: sleep,melatonin,autism,children
cut down on carbohydrate usage in the diet of type 2 diabetes - mechanisms of effective therapy of diabetes by selective choice of macronutrients - the phenotype study

Conditions: Type 2 Diabetes

Summary: scientific evidence for the dietary treatment of type 2 diabetes is insufficient. the investigators hypothesize that a lower carbohydrate content in the diabetic diet than the recommended 55 e% will decrease the postprandial glucose excursion, decrease insulinotropic factors like incretin hormones and decrease their insulinotropic effects due to their glucose dependency. this will reduce postprandial insulin concentration, resulting in an improved insulin sensitivity and glucose metabolism. this clinical study will examine in diabetic, prediabetic and healthy subjects the acute effects of short term highly controlled dietary low carbohydrate intervention on metabolic pathways with respect to insulin action, pancreatic islet function, lipid metabolism, incretin hormones, low grade inflammation in plasma and novel measures of fatty acid metabolism.


Eligibility criteria:
inclusion criteria: * men age 18-70 years * postmenopausal women age 55-70 years * non-smoker (abstinent at least 6 months) * hba1c \< 74 mmol/mol * fasting blood glucose \< 11 mmol/l (mean of 3 measurements) * negative (\<25 iu/l) plasma glutamate decarboxylase (gad-65) antibodies (igg) * hemoglobin \> 7.5 mmol/l (men); \> 6.8 mmol/l (women) * normal thrombocytes (140-400 x 109/l) * egfr \> 45 ml/min per 1.73 m2 * alkaline phosphatase \< 140 iu/l * alanine aminotransferase \< 70 iu/l * normal international normalized ratio (0.9-1.2) exclusion criteria: * critical illness * anti-diabetic drugs other than metformin (maximum of 2000 mg / day) * steroid treatment e.g. prednisolone * reported or journalized severe food allergy or intolerance * reported or journalized gut disease e.g. crohn's disease, coeliac disease * reported or journalized alcohol dependence syndrome
influence of virtual reality games on knee proprioception after anterior cruciate ligament reconstruction (aclr)

Conditions: Motor Activity; Proprioceptive Disorders; Balance; Distorted

Summary: influence of virtual reality games(wii fit) on knee proprioception after anterior cruciate ligament reconstruction (aclr) will be measured in 30 postoperative patients. the age of participants will be ranged from 20 to 30 years old. subjects will be randomly assigned to group a is the study group and group b is the control group.

group a will receive the wii fit protocol of virtual reality games, in addition to the regular exercise rehabilitation protocol, for 3 non-consecutive days per week, for 8 weeks , 40 minutes for each session. group b will receive the regular exercise rehabilitation protocol only for 3 non-consecutive days per week for 8 weeks, 40 minutes for each session. a universal weight and height scale: will be used to measure the patient's bmi. biodex isokinetic dynamometer: will be used to assess the knee proprioception of the affected operated leg at three target angles (30,45,and 60 degrees).

Eligibility criteria:
inclusion criteria: 1. patients who will be in the early postoperative phase (week 2 after surgery) 2. patients with bmi less than 25, and more than 20. exclusion criteria: 1. patients with injury or operation accompanied by the aclr as meniscectomy. 2. patients with any deformities affecting knee joint alignment as genu valgus, genu varus, or genu recurvatum.
illuminoss hand fracture international clinical feasibility study

Conditions: Orthopedic Fractures

Summary: the purpose of this study is to assess the initial safety and technical feasibility of the illuminoss system in the treatment of fractures of bones in the hand.


Eligibility criteria:
inclusion criteria: * skeletally mature * patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure * female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours * acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation * fracture has occurred within past 3 weeks * fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site exclusion criteria: * patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study * patient has experienced a crush, mangling, or burn type injury * patient has probable history of infection or confirmed infection at baseline * patient has previous diagnosis of a significant bone disorder that may impair bone healing * patient has a life expectancy of \< 26 weeks * pathological fracture secondary to tumor * open fracture of gustilo-anderson type ii or iii