Kornimate/medical-research-clean huggingface dataset:
syringe or continuous amnioreduction for symptomatic polyhydramnios. a prospective randomized study.

Conditions: Polyhydramnios

Summary: to compare the efficiency and maternal and fetal tolerance of two techniques of amnioreduction used in cases of symptomatic second and third trimester polyhydramnios: syringe manual aspiration technique (s group) and continuous suction technique (c group) set to - 250 mmhg

polyhydramnios is defined as more than 2 liters of amniotic fluid. ultrasound diagnosis is made either by measurement of a deepest vertical pocket exceeding 8 cm, or by use of an amniotic fluid index (afi) exceeding 25 cm. potential complications of polyhydramnios are preterm labor, premature rupture of membranes, altered utero-placental perfusion, and maternal discomfort. amniodrainage has become an established technique to improve maternal comfort and reduce the risks of severe polyhydramnios in both singleton and twin pregnancies, decreasing uterine contractility, as well as over-stretching of membranes and uterus. it also acts on the pathological processes of twin to twin transfusion syndrome. several techniques are used to reduce symptomatic polyhydramnios. passive gravitational drainage is long, does not allow to evacuate larger amounts of amniotic fluid and continuous maternal and fetal monitoring is difficult. the standard syringe technique is often a source of discomfort for both the patient and the operator. continuous aspiration is faster and limits patient's discomfort. the aim of this study was to compare the efficiency and maternal and fetal tolerance of these two latter techniques of amnioreduction. a preliminary study permitted to assess the depression value created at the tip of the needle during amniodrainage: the syringe aspiration technique showed large depression variations from 0 to - 300 millimeters of mercury (mmhg). the continuous wall suction was thus chosen to be set to - 250 mmhg: depression at the needle's tip didn't vary during the procedure.

Eligibility criteria:
inclusion criteria: * pregnant women with abdomen discumfort and ultrasound diagnosis of polyhydramnios (afi\>25cm) * single or twin pregnancies exclusion criteria: * multiple pregnancy (more than 3 fetuses) * maternal history of placental abruptio * fetus with iugr * pregnancy complicated with pre-eclampsia * unability to give informed consent

Keywords: amniodrainage pregnancy amniocentesis
deployment related mild traumatic brain injury (mtbi)

Conditions: Mild Traumatic Brain Injury

Summary: the study will provide evidence on the long term outcomes of mtbi in service members returning from afghanistan and iraq. in addition, the study will provide evidence on mtbi incidence, and symptom patterns. self-reported assessments at baseline and follow-ups will be combined with data on health care utilization and military job performance. the work, symptoms, and family interaction outcomes of returning soldiers screening positive for mtbi, combined mtbi and ptsd, and soldier controls will be compared at 3 months, 6 months, and at one year. the assessments over time will permit descriptions of symptom changes for these populations. it is likely the study will find similar findings to those of previous civilian studies - that concussive symptoms often resolve within months of injury. however, some soldier subsets may have chronic problems. determining the incidence and outcomes of individuals with mtbi will assist medical providers in determining the types of follow-ups needed by returning service members and suggest the development of additional treatment interventions. these results may also inform treatment of civilian populations with mtbi. the three primary hypotheses are: 1. concussive symptoms at the time of return from serving in afghanistan and iraq and symptoms persisting 3 months, 6 months, and 12 months after return will be associated with extent of exposure to combat, injury mechanism, associated injuries (co-occuring injuries), ptsd and other psychiatric co-morbidities, and number of deployment-related mtbis. 2. returning troops reporting concussive symptoms at the time of return from deployment will have more work related problems at each follow-up (including lower rates of return to duty, return to work, and poor quality of work). 3. the mtbi screening tool will be sensitive and specific to mtbi when compared to the criterion measure, which is a structured interview conducted by clinicians blinded to the screening results.


Eligibility criteria:
inclusion criteria: 1. must be returning from deployment in iraq or afghanistan 2. must have been screened for mild tbi on the deployment related study screening tool 3. must sign an informed consent/hipaa authorization - exclusion criteria: 1. returning from deployment for medical reasons, that is, medically evacuated to the continental us 2. unable or unwilling to provide informed consent/hipaa authorization -

Keywords: traumatic brain injury epidemiology concussion outcomes ptsd prospective longitudinal military symptoms validation screening mild traumatic brain injury
trial to evaluate the efficacy and safety of a new full length recombinant human fviii for hemophilia a

Conditions: Blood Coagulation Disorders; Hemophilia A

Summary: the study will assess the pharmacokinetics (part a) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part b) with bay81-8973 over a one year period (split into two six month treatment periods). the study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per european pharmacopeia (cs/ep) with the classical assay (chromogenic substrate adjusted, cs/adj). during one six month period patients will receive the study drug where the dose has been measured using the" (cs/ep) and during the other six months period the dose will be measured based on the chromogenic substrate adjusted assay cs/adj)


Eligibility criteria:
inclusion criteria: * male, aged 12 to 65 years * severe hemophilia a defined as \< 1% fviii:c * \>/= 150 days of previous treatment with fviii in lifetime * currently receiving on-demand or any type of prophylaxis treatment regimen with any fviii product * no history of or current fviii inhibitors exclusion criteria: * presence of another bleeding disease that is different from hemophilia a (e.g., von willebrand disease, hemophilia b) * low platelet count, abnormal kidney function, or liver disease * received treatment with immune suppressing drugs within the last 3 months prior or requires treatment during the study. (some drugs for hepatitis c, human immunodeficiency virus (hiv), and steroids are allowed) * receiving or has received other experimental drugs within 3 months prior to study entry * allergy to factor viii or hamsters or mouse protein

Keywords: hemophilia a factor viii prophylaxis
a proof of concept pilot trial of alpha-1-antitrypsin for pre-emption of steroid-refractory acute gvhd

Conditions: Graft-versus-host-disease; GVHD

Summary: bone marrow transplant (bmt) patients can develop graft-versus-host disease (gvhd), a serious and potentially fatal complication. the researchers have developed a blood test to identify patients most at risk for developing severe gvhd. patients who consent to this study will have their blood tested up to two times after bmt to determine if they are at high risk for severe gvhd. the tests will be performed one week and two weeks after bmt. patients who are high risk will be treated with a drug called alpha-1-antitrypsin (aat) to see if it prevents the development of severe gvhd. patients will receive 16 doses of aat through a catheter placed into a blood vessel over eight weeks. aat will be given either in the hospital or the outpatient clinic two times per week. patients will be followed for the development of severe gvhd for up to four months from the bmt and will continue to be followed at routine clinic visits for up to one year after bmt.


Eligibility criteria:
inclusion criteria: * high risk prediction score as determined by the mount sinai acute gvhd international consortium (magic) algorithm at either day 7 or day 14 post hematopoietic cell transplant (hct). * any donor type (e.g., related, unrelated) or stem cell source (bone marrow, peripheral blood, cord blood). * donor and recipient match each other for at least 7/8 hla-loci (hla-a, b, c, and dr) * any conditioning regimen (non-myeloablative, myeloablative, or reduced intensity) is acceptable. * gvhd prophylaxis must include a calcineurin inhibitor combined with methotrexate or mycophenolate. * the use of serotherapy to prevent gvhd (e.g., antithymocyte globulin) prior to day 3 post-hct is permitted * direct bilirubin must be \<2 mg/dl unless the elevation is known to be due to gilbert syndrome within 3 days prior to enrollment. * alt/sgpt and ast/sgot must be \<5 x the upper limit of the normal range within 3 days prior to enrollment. * signed and dated written informed consent obtained from patient or legal representative. exclusion criteria: * patients who develop acute gvhd prior to start of study drug * patients at very high risk for relapse post hct as defined by very high disease risk index * patients participating in a clinical trial where prevention of gvhd is the primary endpoint * uncontrolled active infection (i.e., progressive symptoms related to infection despite treatment or persistently positive microbiological cultures despite treatment or any other evidence of severe sepsis) * patients who are pregnant * patients on dialysis within 7 days of enrollment * patients requiring ventilator support or oxygen supplementation exceeding 40% fio2 within 14 days of enrollment. * patients receiving investigational agent within 30 days of enrollment. however, the principal investigator (pi) may approve prior use of an investigational agent if the agent is not expected to interfere with the safety or the efficacy of alpha-1-antitrypsin. * history of allergic reaction to alpha-1-antitrypsin
comparative acceptability of tobacco and menthol flavored e-cigarettes

Conditions: Tobacco Use Disorder

Summary: the study is a randomized crossover trial. current menthol smokers will complete a session with each flavor of an electronic cigarette: menthol and tobacco. the objective of this survey is to assess for flavor preference.

participants who report typically smoking menthol cigarettes will be invited to complete a session. participants will undergo overnight tobacco/nicotine abstinence before the visit (eco\<12ppm). participants will then be randomized 1:1 to e-cigarette flavor order (tobacco e-cigarette, menthol e-cigarette). they will complete a 30-minute ad libitum session with the first product, based on randomization, followed by a 1.5 hour standard washout period, followed by a 30-minute ad libitum vaping session with the second product. throughout each session, puff topography will be measured via a pressure sensor attached to the e-cigarette device. participants will complete self-report measures of smoking urges and withdrawal symptoms pre- and post-vaping session. in addition, they will complete measures of subjective vaping experience, perceptions of flavor, product demand, and intentions for future use.

Eligibility criteria:
inclusion criteria: * typically smoking menthol cigarettes * non-hispanic african american or white/caucasian, * ≥21 years old, smoke 5-30 cigarettes per day, * daily cigarette smoker * smoked at current rate for at least 6 months * interested in trying e-cigarettes * not interested in or unable/unwilling to quit cigarette smoking * willing to complete one in-person study visits exclusion criteria: * interested in quitting cigarettes in the next 30 days * use of smoking cessation pharmacotherapy in the past 30 days * use of non-cigarette tobacco products in the past 30 days * use of e-cigarettes \>5x in lifetime * use of e-cigarettes ≥4 of the past 30 days * weight \< 110 lbs * uncontrolled hypertension (systolic bp ≥ 180 or diastolic bp ≥ 105) * pregnant, plans to become pregnant, or breastfeeding * live \>10 miles from study site (fairway cru) * current enrollment is a research study or program that aims to alter tobacco use

Keywords: tobacco e-cigarette
characters of epiretinal membranes in patients with previous vitrectomy for retinal detachment

Conditions: Rhegmatogenous Retinal Detachment of Both Eyes (Diagnosis)

Summary: 31 patients were included in the study,15 cases with erm in silicone filled eyes and 16 eyes with idiopathic erm

this is a prospective study that included 31 patients and was performed in tanta university eye hospital in cooperation with the pathology department, tanta university, between january 2018 and june 2019. the approval of the ethical committee of the faculty of medicine in tanta university was obtained, and the study was conducted in accordance with the 1964 helsinki declaration and its later amendment. a detailed informed written consent was signed by all study participants. the research is not funded by the university or any organization or entity. fifteen cases had pars plana vitrectomy for rhegmatogenous retinal detachment nine months earlier with erm detected by oct one day before silicone oil removal. the other 16 cases matched for age and gender with idiopathic erm and were included as a control. histopathological features of the erms were compared between the two groups. all patients have undergone complete ophthalmic evaluation including: best corrected visual acuity (bcva) by snellen chart that was converted to log mar for statistical analysis, anterior segment examination by slit lamp, posterior segment examination by slit lamp bimicroscopy using +78 d lens and indirect ophthalmoscopy, and spectral domain optical coherence tomography (sd-oct) (spectralis; heidelberg engineering,heidelberg, germany) was performed for all patients before surgery. the investigators excluded patients with previous intraocular surgery (except cataract surgery) for the control group, diabetes mellitus/diabetic retinopathy, coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration, previous laser photocoagulation, intravitreal injection of triamcinolone acetonide or antivascular endothelial growth factor (anti-vegf) agents, prior intra-ocular inflammation, retinal degenerations, neovascularization or rubeosis and vascular disorders e.g. retinal vein or artery occlusion.

Eligibility criteria:
inclusion criteria: 1. fifteen cases had pars plana vitrectomy for rhegmatogenous retinal detachment nine months earlier with erm detected by oct one day before silicone oil removal. 2. the other 16 cases matched for age and gender with idiopathic erm and were included as a control. histopathological features of the erms were compared between the two groups. - exclusion criteria:the investigator excluded 1-patients with previous intraocular surgery (except cataract surgery) for the control group. 2- diabetes mellitus/diabetic retinopathy. 3-coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration. 4-previous laser photocoagulation, intravitreal injection of triamcinolone acetonide or antivascular endothelial growth factor (anti-vegf) agents. 5- prior intra-ocular inflammation, retinal degenerations. 6-neovascularization or rubeosis and vascular disorders e.g. retinal vein or artery occlusion. -
dce-mri using dotarem® in evaluation of therapeutic response to sorafenib in patients with advanced stage hcc

Conditions: Hepatocellular Carcinoma

Summary: the main objective is to evaluate the value of dynamic contrast-enhanced magnetic resonance imaging (dce-mri) in prediction of response of patients with hepatocellular carcinoma (hcc) to treatment with sorafenib assessed by mrecist.

one of the secondary objectives was to evaluate the correlation between dce-mri perfusion parameters at baseline and: * overall survival (os) * progression-free survival (pfs) * time to progression (ttp) three dce-mri examinations were done during the study: * at the enrolment and initiation of the sorafenib treatment * one week after initiation of the sorafenib treatment * two weeks after initiation of the sorafenib treatment dce-mri perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of sorafenib treatment), week 1 and week 2. according to mrecist criteria, hcc lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). os, pfs and ttp were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.

Eligibility criteria:
1. male and female adult patients (age ≥ 20 years old) 2. patients diagnosed with unresectable hcc \[child pugh class a and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times\] 3. presence of mrecist target lesion within liver \[lesion which can be classified as a recist measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion suitable for repeated measure, lesion showing intraluminal arterial enhancement on contrast-enhanced ct or mri\] 4. patients planned to be treated with sorafenib 5. patient with liver ct performed or planned to be performed within 4 weeks before initiation of sorafenib treatment 6. patient with a life expectancy of 12 weeks or more 7. no previous treatment with sorafenib 8. female patients who are surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or who have a documented negative urine hcg test at screening

Keywords: dce-mri sorafenib response
vitamin d insufficiency investigation among hospitalized inpatients

Conditions: Hypovitaminosis D

Summary: hypovitaminosis d is common in the adult population, it affects at least 1 billion people worldwide, and in particular 80% of the french population according to the national institute for public health surveillance. hypovitaminosis d is accompanied or complicated by deleterious health manifestations such as bone, immune and cancer diseases, neuromuscular disorders and a propensity to fall, for example. hypovitaminosis d has also been associated with more complicated care pathways (increase in the severity of the reason for hospitalization, length of hospitalization, risk of in-hospital death). prevention of these clinical events depends on correcting vitamin d status. in sick, dependent or fragile adults, natural intakes are generally insufficient. it is indeed accepted that hypovitaminosis d may not be treated effectively by dietary measures or by simple exposure to the sun in french latitudes. drug supplementation is therefore necessary, with the objective of achieving a target concentration of circulating 25-hydroxyvitamin d (25 (oh) d) of 75 nmol / l (30 ng / ml) in this population. vitamin d supplementation, when properly conducted, corrects hypovitaminosis d, and has been associated with improved prognosis, especially life-saving, in therapeutic trials versus placebo. such results lead the investigators to suggest that the identification and correction of hypovitaminosis d in hospitalized patients could represent a simple, effective and inexpensive strategy for improving hospital care pathways. in this perspective, the first step is to determine the prevalence, severity and clinical profile of hospitalized patients with hypovitaminosis d, as well as their course of care. to the investigators knowledge, there are no large-scale studies based on real-life data on this subject.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * have had a dosage of circulating 25-hydroxyvitamin d (plasma or serum) in a hugo establishment * consultant or hospitalized between 01/01/2015 and 12/31/2019 in one of the participating hugos. exclusion criteria: * none
method study: bilateral tap block with 24 hours infusion

Conditions: Postoperative Pain

Summary: the purpose of this method study in healthy volunteers is to determine the extent of sensory block following transversus abdominis plane (tap) block with 24 hours infusion of ropivacaine versus infusion of saline. furthermore, to determined the analgesic effect of the tap block and the influence on the lung function.


Eligibility criteria:
inclusion criteria: * age between 18 and 30 years * written consent * asa 1 * bmi between 18 and 25 * males exclusion criteria: * unable to communicate in danish * relevant drug allergy * alcohol or/and drug abuse * daily intake of prescription pain medication the last 4 weeks * pain medication in the last 48 hours * previously operated abdominal

Keywords: transversus abdominis plane block postoperative pain postoperative pain management
evaluation of optimal dose of local anesthetics for patient controlled continuous femoral nerve block

Conditions: Arthropathy of Knee Joint

Summary: to evaluate an analgesic effect without basal administration of local anesthetics for patient-controlled femoral nerve block (with sciatic nerve block) after total knee arthroplasty.


Eligibility criteria:
inclusion criteria: * patients older than 20 yrs old scheduled for total knee arthroplasty exclusion criteria: * none
a crossover study in the treatment of patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to compare the efficacy of formoterol fumarate inhalation solution (ffis) 20 mcg bid to combivent® inhalation aerosol \[2 inhalations from metered dose inhaler (mdi)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate qid\], and to compare the preference/compliance of bid nebulization to qid use of mdi


Eligibility criteria:
inclusion criteria: * diagnosis of copd * smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day * meet lung function requirements exclusion criteria: * diagnosis of asthma * significant disease other than copd * female pregnant or lactating or planning to become pregnant

Keywords: copd formoterol ipratropium crossover
a new scoring system for prediction of pda

Conditions: Patent Ductus Arteriosus; Prematurity; Extreme

Summary: patent ductus arteriosus (pda) is an important morbidity of that the diagnosis and treatment is controversy in premature infants. a number of scoring systems have been developed, including the findings of echocardiography on the diagnosis and treatment of pda. this study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant pda earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

this study aimed to develop a new clinical scoring system that will enable the rapid, standard and noninvasive evaluation of hemodynamically significant pda earlier, without relying on echocardiographic findings in premature babies with extremely low birth weight, and to determine the role of this scoring system in early diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * informed consent obtained from parents * extremely preterm infants * infants born before 28 gestational week exclusion criteria: * lack of informed consent * chromosomal abnormality * cardiovascular abnormality