Kornimate/medical-research-clean huggingface dataset:
pessary as adjunctive therapy to cerclage for the prevention of preterm birth

Conditions: Preterm Birth

Summary: cervical cerclage was devised in the 1950's for women with prior early preterm births (ptb) who developed a dilated cervix detected by manual exam in the second trimester. in contemporary practice, there are three possible indications for cerclage. history-indicated cerclage (hic) is defined as a cerclage placed usually between 12-15 weeks based solely on poor prior obstetrical history, e.g. multiple second trimester losses due to painless dilatation. ultrasound-indicated cerclage (uic) is defined as a cerclage placed usually between 16-23 weeks for transvaginal ultrasound (tvu) cervical length (cl) \< 25mm in a woman with a prior spontaneous ptb. physical-exam indicated is defined as a cerclage placed usually between 16-23 weeks because of cervical dilatation of 1 or more centimeters detected on physical (manual) examination. randomized trials and meta-analysis of these have shown that uic is associated with significant reduction in ptb and improved neonatal outcome, whereas evidence of efficacy for history-indicated cerclage and physical exam-indicated cerclage is limited. in the united states, the national data shows that the rate of cerclage has decreased in the last few years. the indications of placement of cerclage have recently changed, and so it is important to evaluate how many women are getting this procedure. with the recent completion of clinical trials, it is plausible that obstetricians and perinatologists may have become more selective in terms of the best candidates for cerclage. the aim of this rct is to evaluate the efficacy of cervical pessary in prevention of ptb as adjuctive therapy in women with uic


Eligibility criteria:
inclusion criteria: * 18-50 years of age * singleton gestations * women with prior preterm birth and with short cervical length (tvu cl \<25 mm) who underwent uic exclusion criteria: * multiple gestation * ruptured membranes * lethal fetal structural anomaly * fetal chromosomal abnormality * vaginal bleeding * suspicion of chorioamnionitis * ballooning of membranes outside the cervix into the vagina * painful regular uterine contractions * labor * placenta previa
single-lumen 5fr and triple-lumen 6fr piccs are accurate for hemodynamic measurement by transpulmonary thermodilution.

Conditions: Peripherally Inserted Central Catheters; Centrally Inserted Central Catheter; Transpulmonary Thermodilution; Hemodynamic Monitoring

Summary: peripherally inserted central catheters (piccs) are increasingly used in intensive care unit (icu) as an alternative to centrally inserted central catheters (ciccs) for intravenous infusion. in the present study the investigators try to assess their reliability for measuring cardiac index (ci) with trans-pulmonary thermodilution (tptd) technique.


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) admitted to the icu * patients requiring hemodynamic monitoring using ev1000tm * patients having both picc and cicc in place (these patients had their picc replaced with a cicc, usually at the time of icu admission, or vice versa, usually at the end of their icu stay, and were enrolled immediately after the placement of the new device before the previous one was removed) exclusion criteria: * body weight \<40 kg * severe aortic regurgitation or intra-cardiac shunt * treatment with an intra-aortic balloon pump * contraindication for placement of picc, cicc or a femoral arterial catheter * abdominal aneurism * extracorporeal circulation * pregnancy * lack of informed consent

Keywords: picc cicc cardiac output shock
health care use during the covid19 crisis

Conditions: Health Care Utilization

Summary: the project us3r is a general population survey that will measure the magnitude of utilised, postponed and foregone medical care in relation with other health care needs than coronavirus symptoms during the confinement period in belgium. the study aims to describe the magnitude of unsatisfied health care needs for various types of care. it will also identify the reasons for these postponed and foregone care according to gender, health and socioeconomic status.

context: belgium has put in place confinement measures on march 13th 2020 with the aim to reduce contagion related to covid19 in the population and manage the number of patients to be treated in the hospital. however, some weeks after those confinement measures, health care professionals are worry about other patients than covid19 since they have observed a significantly lower use of emergency services, cancellations of screening appointments, interrupted health care in patients with chronic conditions, disabilities, or mental health disorders. objectives: to collect data on used, postponed and foregone medical care related to other health care needs than covid19 during the confinement period in belgium; to measure the magnitude of unsatisfied health care needs for various types of care; to identify the reasons explained postponed and foregone care methods : the survey is made of about 50 questions collecting self-reported data on health care use and non-use for various types of care along with demographics, socioeconomics and health status characteristics during the confinement period . data will be analysed with stata 15 using statistical tests and regression models. participants are collected via social media platforms and institutionnal mailing, and belgian newspapers.

Eligibility criteria:
inclusion criteria: * living in belgium * more than 18 exclusion criteria: * living outside belgium * less than 18

Keywords: foregone care postponed care covid19 confinement
parent-qol and sleep disordered breathing

Conditions: Sleep Apnea Syndromes

Summary: in this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who were planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. a group of parents to healthy children will comprise the control group.

parents of children with any chronic illness may experience increased anxiety and reduced health-related quality of life (qol). in this study, the investigators will analyze qol parameters among parents of obstructive sleep disordered breathing (osdb) children before and after surgical treatment. in this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who are planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. a group of parents to healthy children will comprisedthe control group. the investigators will translate and validate the par-ent-qol questionnaire through forward-backward translation method. main outcome measure: the questionnaire was tested for reliability, consistency, reproducibility, responsiveness, and for its clinical use.

Eligibility criteria:
inclusion criteria: * parents of children younger than five years old who suffered from osdb and underwent tonsillectomy or tonsillotomy with or without adenoidectomy exclusion criteria: * we excluded parents of children who required immediate surgery or had any other chronic diseases (such as adhd, asthma, allergic rhinitis or severe medical or mental impairments).
a study to evaluate the efficacy and safety of ad-223

Conditions: Hypertension,Essential

Summary: the purpose of this study is to evaluate the efficacy and safety of ad-223

condition or disease : hypertension

Eligibility criteria:
inclusion criteria: * signed informed consent * other inclusions applied exclusion criteria: * orthostatic hypotension with symptom * other exclusions applied
a study to evaluate the pharmacokinetics of pci-32765 in participants with varying degrees of hepatic impairment

Conditions: Hepatic Impairment

Summary: the purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of pci 32765 in participants with mild, moderate, or severe hepatic impairment.

this is an open-label (all people know the identity of the intervention), single-dose, multi-center (study conducted at multiple sites), non-randomized study to access the pharmacokinetics of pci-32765 in participants who either have mild, moderate, or severe hepatic impairment or qualify for the control group (normal liver function). the study mainly consists of 3 phases: screening phase (within 21 days prior to the first dose of study medication), treatment phase, and a follow up phase (10 to 12 days after the last dose of study medication). in the treatment phase, participants will receive single oral dose of pci-32765 on day 1. liver impairment will be classified according to the child-pugh classification of severity of liver disease, as: normal, mild, moderate, and severe. total 30 participants (24 with hepatic impairment \[6 mild, 9 moderate and 9 severe\] at baseline and 6 in the control group according to child-pugh criteria) will be enrolled. participants in the control group will be enrolled after the participants with mild or moderate hepatic impairment have completed the study. safety evaluations for adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. the total duration of study for each participant will be approximately for 29 to 33 days.

Eligibility criteria:
inclusion criteria: * stable hepatic function as confirmed by the serum bilirubin and transaminase levels measured during screening and those measured within 48 hours prior to pci-32765 administration * must be hepatically impaired as defined by the child-pugh classification of severity of liver disease * control group must have good health with normal liver function * participants with controlled hypertension and those with problems directly associated with the primary diagnosis of hepatic impairment * concomitant medications to treat underlying disease states or medical conditions related to hepatic impairment are allowed * agrees to protocol-defined use of effective contraception exclusion criteria: * clinically significant renal laboratory findings including serum creatinine more than 1.5 x the upper limit of normal (uln) and/or calculated creatinine clearance of less than 60 ml per minute per 1.73 square meter * clinically significant abnormal laboratory tests, physical examination, vital signs or electrocardiogram at screening or at admission to the study center * antiviral therapy for active hepatitis infection at time of screening * use of any anti-coagulation therapy including vitamin k antagonists, low molecular weight heparin, or other anticoagulants

Keywords: hepatic impairment pci 32765 metabolite pci-45227 pharmacokinetics
description and modeling of swallowing disorders after a stroke

Conditions: Stroke; Swallowing Disorders

Summary: the oropharyngeal junction participates in 3 interpenetrating functions: swallowing, breathing and speech. in the context of ischemic or hemorrhagic stroke, these are altered, isolated or associated manner, causing major disorders and representing a source of handicap for patients. understanding the swallowing mechanisms is therefore a major challenge to guide the rehabilitation and improve the initial and long-term prognosis of patients with stroke. the main objective of this study is to describe and modeling, thanks to a clinical, physiological and radiological knowledge base, swallowing, speech and breathing, in patients with stroke and in healthy subjects.


Eligibility criteria:
for patients after stroke inclusion criteria: * first stroke confirmed by mri \< 15 days * no severe leukoaraiosis * swallowing disorders identified (guss scale \< 20) * neurological deficit identified (nihss scale \<15) * patient able to cooperate for investigations * informed consent signed exclusion criteria: * cerebral hemorrhage * history of neurological disease that can lead to swallowing disorders * history of laryngological disease such as previous surgery or radiation neck * tracheotomy * vigilance disorders * pregnant, parturient or nursing woman * protected adult * simultaneous participation in another study * non registered to the french social security system for healthy subjects inclusion criteria : * age between 18 and 40 years old * french native speaker * normal hearing with or without corrective * no oral or written language disorders * no neurological or psychiatric disorders * informed consent signed exclusion criteria * mri contraindication * pregnant, parturient or nursing woman * simultaneous participation in another study * non registered to the french social security system
study assessing efficacy and safety of akst4290 in subjects with parkinson's disease on stable dopaminergic treatment

Conditions: Parkinson Disease

Summary: this study will evaluate the efficacy and safety of akst4290 in subjects with parkinson's disease who are currently on stable dopaminergic treatment.


Eligibility criteria:
key inclusion criteria: * diagnosis of clinically established or clinically probable pd according to mds-pd criteria with at least 1 year of pd symptoms. * modified hoehn and yahr ≤2.5. * have notable motor worsening during off-medication state. * clear-cut improvement of motor response to levodopa medications, as assessed by the investigator. * must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine oxidase inhibitors, catechol-o-methyl transferase inhibitors, amantadine), for at least 8 weeks prior to enrollment and remain on stable dose during the 12-week treatment period. * female subjects must not be pregnant or breastfeeding. women of childbearing potential (wocbp) must have a negative pregnancy test at screening. wocbp must agree to use highly effective contraception prior to study entry. male subjects must be willing to use a barrier method of contraception. key exclusion criteria: * secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, lewy body dementia. * history of any brain surgery for pd (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplant). * conditions affecting the peripheral or central nervous system, unless related to pd, that would affect the ability to adequately perform the mds-updrs and motor assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke affecting motor or gait function. * significant alcohol or drug abuse within past 2 years. * based on ecg reading, subjects with a risk of qt prolongation. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: brain diseases central nervous system diseases nervous system diseases neurodegenerative diseases neurocognitive disorders mental disorders parkinson's disease dementia movement disorder shaking palsy
intravitreal pegaptanib in treatment of choroidal neovascularisation secondary to pathologic myopia

Conditions: Myopic Choroidal Neovascular Membrane

Summary: intravitreal pegaptanib for treatment of choroidal neovascularisation secondary to pathologic myopia

this is a prospective interventional, non-comparative study in 20 consecutive patients who will be selected from the outpatient services. after taking an informed consent, the patients will be given intravitreal pegaptanib 0.3 mg every 6 weeks for 3 procedure of injection. thereafter, patients will continue to be examined every 6 weeks (± 2 weeks) and of may receive additional injections as needed based on the presence of one or more re-treatment criteria (please see below). final assessment will be done at 54 weeks and all the baseline investigations will be performed.

Eligibility criteria:
inclusion criteria: 1. should be willing to participate in the trial. 2. age less than 55 years. 3. best corrected visual acuity (bcva) score of at least 5 letters (20/200), as assessed by etdrs chart. 4. myopia of ≥ 6 diopters. 5. fluorescein angiographic documentation of cnv. exclusion criteria: 1. ocular causes, or other ocular disorders leading to vision loss. 2. maculopathy not related to pathologic myopia. 3. pregnancy, lactation. 4. not willing to provide an informed consent. 5. history of previous macular laser including pdt. 6. other forms of therapy including intravitreal injections. 7. history of intraocular surgery in the past 3 months. 8. anticipated cataract surgery in the next 6 months. 9. any active infection or inflammation in the eye. 10. cases where good quality imaging is not possible, either due to hazy media or extremely high myopia. 11. patients with uncontrolled glaucoma, with iop \> 21mm hg on 2 or more medications. 12. patients with subfoveal scar or significant subretinal haemorrhage occupying more than 50% of lesion size. 13. eyes with previous retinal detachment.

Keywords: pegaptanib, myopic cnvm, intravitreal anti-vegf
use of propofol as a sedative agent versus spinal analgesia with bupivacaine in external cephalic version

Conditions: Pregnancy Complications

Summary: external cephalic version (ecv) is a maneuver to modify fetal position in pregnant women with a non-cephalic presentation. its objective is to achieve a cephalic presentation that allows for vaginal delivery with less risk than a vaginal breech delivery or a cesarean section. ecv is an effective technique to reduce the rate of cesarean sections and is recommended by the spanish society of obstetrics and gynecology (sego) and the world health organization (who) cesarean section working group. the who aims to reduce interventionism in childbirth globally and implement non-clinical measures to reduce the rate of unnecessary cesarean sections. despite propofol is a sedative agent commonly used by anesthesiologist in countless ambulatory procedures in obstetric anaesthesia, it has been little studied in ecv, and its effect has not been compared with other commonly used agents such as remifentanil or spinal analgesia. the obstetric anesthesiology section of the spanish society of anesthesiology and resuscitation recommends the use of locoregional analgesia in ecv.

this project involves a randomized clinical trial to compare the effect of sedation with propofol versus spinal analgesia in ecv. therefore, the objectives of this study are: * to compare the effect of sedation with propofol on the success rate of ecv compared to spinal analgesia. * to compare the effect of sedation with propofol on the rate of complications of ecv compared to spinal analgesia. * to compare the effect of sedation with propofol on the length of hospital stay of ecv compared to spinal analgesia. locoregional analgesia requires a longer hospital stay than sedation with propofol and may mask an early diagnosis of complications after ecv, such as placental abruption, which is identified in the initial stages by intense abdominal pain.

Eligibility criteria:
inclusion criteria: * voluntary participation. * older than 18 years. * non-cephalic presentation. * desire to attempt a vaginal birth. * normal blood count and coagulation prior to the intervention exclusion criteria: * age under 18 years old. * multiple gestation. * cephalic presentation. * risk of fetal compromise. * unexplained active bleeding. * absolute contraindication for vaginal delivery (placenta previa) * 2 or more previous cesarean sections. * previous myomectomy with entry into the uterine cavity * maternal fever. * thrombocytopenia (\<85,000 platelets). * maternal spinal anomaly. * intolerance or allergy to propofol or any of its components. * intolerance or allergy to bupivacaine or any of its components. * contraindication for intrathecal sedation or analgesia
simplus and eson non-invasive ventilation (niv) evaluation - germany

Conditions: Obesity Hypoventilation Syndrome; Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Neuromuscular Disease

Summary: this investigation is designed to evaluate the performance, comfort and ease of use of the simplus and eson masks amongst niv patients who are currently on bi-level therapy

up to 40 niv patients who currently use a full face mask or a nasal mask will be recruited. they will be issued a simplus (if they are existing full face users) or eson (if they are existing nasal users) to use in-home for 2 weeks. this will consists of male and female participants who have been prescribed with niv therapy for at least 3 months.

Eligibility criteria:
inclusion criteria: * aged 18+ * existing full face mask user or a nasal mask user * prescribed niv therapy for at least 3 months exclusion criteria: * inability to give informed consent * pregnant or think they may be pregnant * anatomical or physiological conditions making nivtherapy inappropriate * patients who are in a coma or decreased level of consciousness * existing simplus and eson users
randomized study with oxaliplatin in 2nd line pancreatic cancer

Conditions: Pancreatic Neoplasms

Summary: primary objective: to demonstrate that the addition of oxaliplatin to 5-fluorouracil (5-fu) and leucovorin (lv) will improve the progression-free survival (pfs). progression is based on recist (response evaluation criteria in solid tumors) criteria or death secondary objective: to evaluate other measures of tumor responses, safety, quality of life (qol), and health utility assessment.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven pancreatic carcinoma * measurable locally advanced or metastatic disease * patient previously treated with 5-fu as a "radiation sensitizer" and all toxicities must have been resolved * patients must have received gemcitabine-based chemotherapy (single agent or combination) as 1st line therapy for advanced or metastatic disease and all toxicities must have been resolved * patients received the last dose of gemcitabine at least 2 weeks prior to randomization * confirmed radiographic disease progression (computed tomogram (ct) scan or magnetic resonance imaging (mri) within 4 weeks prior to randomization * adequate liver and kidney function: * total bilirubin inferior than 1.5 upper limit of normal (uln) * creatinine clearance (clcr) superior than 50 ml / min * aspartate transferase (ast) inferior than 3 uln if no liver metastasis or ast inferior than 5 uln if liver metastasis * alanine aminotransferase (alt) inferior than 3 uln if no liver metastasis or alt inferior than 5 uln if liver metastasis * adequate hematological function: * neutrophils superior or egal to 1.5 x 109/l * platelets superior or egal to 100 x 109/l exclusion criteria: * peripheral sensory or motor neuropathy \> grade 1 * eastern cooperative oncology group (ecog) performance status \> 2 * serious cardiac arrhythmia, diabetes, or serious active infection or other active illness that would preclude study participation in the opinion of the investigator * pernicious anemia or other megaloblastic anemia with vitamin b12 deficiency * previous (greater than 5 years) or current malignancies of other origin within the past 5 years * lack of physical integrity of the upper gastrointestinal tract, clinically significant malabsorption syndrome, or inability to take oral medications * history of known allergy to oxaliplatin or other platinum compounds, to 5-fu, to lv or to any ingredients in the formulations or the containers * severe renal impairment (clcr \< 50 ml/min) * pregnant women or breast-feeding * patients (male or female) with reproductive potential not implementing accepted and effective method of contraception (the definition of "effective method of contraception" will be based on the investigators' judgment) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.