Kornimate/medical-research-clean huggingface dataset:
pipac for peritoneal metastases

Conditions: Peritoneal Metastases

Summary: pressurized intraperitoneal aerosol chemotherapy (pipac) is a novel drug delivery system that allows the direct application of chemotherapeutic agents into the peritoneal cavity. it boosts improved distribution, enhanced tissue uptake and repeatability using minimally invasive access. it was devised to palliate the local symptoms of extensive peritoneal metastases (pm) in patients who are not amenable to curative surgery. this study is to determine safety and feasibility of pipac in patients with pm from gastrointestinal (gi) cancer, hepato-pancreato-biliary (hpb) cancer, and other rare malignancies.


Eligibility criteria:
inclusion criteria: for unesectable pm group: * age ≥ 21 years old * ecog \< 3 * fit for systemic chemotherapy treatment * adequate bone marrow function (haemoglobin ≥ 8.0 mmol/l, neutrophils ≥ 1.5x109/l, platelets ≥ 100x109/l * adequate renal function (e-gfr \> 30mls/min for patients undergoing pipac with oxaliplatin; e-gfr \> 60mls/min for patients undergoing pipac with doxorubicine/cisplatin) * adequate liver function (total bilirubin \< 1.5 upper limit of normal; alt and ast\< 3 upper limit of normal) * no contraindications to chemotherapy agents oxaliplatin, doxorubicin/ cisplatin * no contraindications to general anaesthesia and diagnostic laproscopy procedure * normal left ventricular ejection fraction (for patients undergoing pipac with doxorubicin/ cisplatin) * histological/ cytological proof of pm from gi, hpb, gynaecology, breast, sarcoma primaries * peritoneal-dominant metastatic disease for the extensive pm group: all the above mentioned criteria as for the unresectable group, with the addition of the following: * not suitable for curative cytoreductive surgery (crs) \& hyperthermic intraperitoneal chemotherapy (hipec) surgery after diagnostic laproscopy - pci \> 18 in lgi, pci \> 6 in ugi ecog \< 3 * in ugi pm patients, progression while on bidirectional chemotherapy exclusion criteria: * patient is medically unfit for surgery due to concurrent medical comorbidities, including but not limited to intestinal obstruction, multiple sites of metastases * any medical or psychiatric condition(s) which would preclude informed consent * patient is pregnant or nursing * gi pm patients with pci \>6 but are treatment naive (these patients should undergo standard treatment - bidirectional intravenous and intraperitoneal chemotherapy)
post-thoracotomy closure study

Conditions: Post Thoracotomy Pain Syndrome

Summary: post-thoracotomy pain syndrome (ptps) is defined as "pain that recurs or persists along a thoracotomy scar at least 2 months following surgery." ptps presents a frustrating challenge to patients and healthcare providers alike. ptps can affect up to 80% of patients undergoing thoracotomies, and results in significant impairment. a proposed mechanism for ptps is the compression of the intercostal nerves during routine closure. closure of thoracotomies using intracostal sutures is a novel technique where sutures are passed through holes drilled into the rib; thus, avoiding compression of the nerves. we propose a double-blind, randomized control study involving 90 patients undergoing elective posterolateral thoracotomies. participants will be randomly assigned to undergo thoracotomy closure with pericostal sutures or intracostal sutures. our primary outcome will assess the incidence and severity of ptps at 3, 6, and 12 months after surgery between groups.


Eligibility criteria:
inclusion criteria: * patients 18-88 years age * patients undergoing surgery with an open thoracotomy incision exclusion criteria: * patient refusal * inability to give informed consent * concurrent drug addiction or methadone use * present chronic pain syndrome * significant psychiatric illness excluding depression * cannot understand english, read or write in english independently

Keywords: neuropathic pain symptoms intracostal closure technique pericostal suture closure technique post surgical pain post thoracotomy pain
follow up to the avant study up to 8 and 10 years (median follow up) in patients with colon carcinoma

Conditions: Colon Cancer Treated With Bevacizumab After Colon Surgery

Summary: the aim of the s-avant study is to collect additional data at 8 and 10 years median follow up of patients previously included in the avant trial from december 2004 to june 2007. clinical data of the avant trial will be updated. neither additional examination nor administration of any treatment will be performed on the patients. 330 centers in 34 countries participated to the avant trial (australia, austria , belgium, brazil, bulgaria, canada, china/hong-kong, czeck republic, finland, france, germany, greece, hungary, israël, italy, japan, korean republic, mexico, netherlands, new zealand, norway, panama, poland, portugal, russia federation, singapore, south africa, spain, sweden, switzerland, taïwan, thaïland, united kingdom, u.s.a). the avant study aiming at demonstrating superiority of bevacizumab in combination with folfox-4 or xelox compared to folfox-4, did not show prolongation of dfs at 3 year when adding bevacizumab to chemotherapy in resected stage iii colon cancer. adverse events were consistent with the known safety profile of bevacizumab. however, more relapses and deaths due to disease progression have been observed in both bevacizumab arms. a more prolonged follow-up is necessary to assess overall survival and to evaluate long-term results and safety. collection of additional follow-up data will start q3 2014. clinical data are to be collected at 8-year median follow-up (expected to be reached around q2 2014) and at 10-year median follow-up (expected to be reached around q2 2016). all analyses will be performed on an exploratory purpose only. an analysis at 8 years median follow-up and a final analysis at 10 years median follow-up will be performed in the main population (all randomized patients in the avant trial including patients lost to follow up or died).


Eligibility criteria:
inclusion criteria: * all patients randomized in the avant trial. exclusion criteria: * written opposition from alive patients

Keywords: avant gercor follow up colon cancer bevacizumab overall survival
a proof-of-mechanism study to determine the effect of danicopan on c3 levels in participants with c3g or ic-mpgn

Conditions: C3 Glomerulonephritis; Dense Deposit Disease; C3 Glomerulopathy; Immune Complex Mediated Membranoproliferative Glomerulonephritis; Membranoproliferative Glomerulonephritis Types I, II, and III

Summary: the primary objective of this study was to determine whether ach-0144471 (also known as danicopan and alxn2040) increases blood c3 complement protein (c3) levels in participants with low c3 levels due to either c3g or ic-mpgn.


Eligibility criteria:
key inclusion criteria: * must have had clinical diagnosis of c3g (c3 glomerulonephritis or dense deposit disease, the 2 types of c3g) or idiopathic ic-mpgn by renal biopsy for at least 3 months prior to dosing, with the pathologic diagnosis verified by a review of the renal biopsy by the study central pathologist * c3 must have been \<50% of the lower limit of normal * c4 complement protein (c4) must have been \>90% of the lower limit of normal * must have been willing to comply with study-specific vaccination requirements for haemophilus influenzae, streptococcus pneumoniae, and neisseria meningitidis strains a, c, w, and y * negative pregnancy test for females prior to dosing and throughout the study key exclusion criteria: * history of a major organ transplant (for example, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. individuals receiving renal replacement therapy were also excluded * evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which c3g or ic-mpgn may have been secondary * estimated glomerular filtration rate (using modification of diet in renal disease equation) \<45 milliliters/minute/1.73 square meters at the time of screening or at any time over the preceding 4 weeks * receipt of eculizumab at any dose or interval within the past 75 days prior to dosing * use of tacrolimus or cyclosporine within 2 weeks of the first dose of danicopan * history of febrile illness, a body temperature \>38°celsius, or other evidence of a clinically significant active infection, within 14 days prior to study drug administration * history of meningococcal infection, or a first-degree relative or household contact with a history of meningococcal infection * females who were pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration or participants with a female partner who was pregnant, nursing, or planning to become pregnant during the study or within 90 days of study drug administration

Keywords: factor d fd alternative pathway complement mediated disease idiopathic mpgn mpgn type i mpgn type ii mpgn type iii primary mpgn mcgn mesangiocapillary glomerulonephritis c3 glomerulopathy c3g membranoproliferative glomerulonephritis c3gn dense deposit disease ddd
multicenter study of the avenue l interbody spinal fusion system using vertebridge plating and posterior fixation

Conditions: Degenerative Disc Disease

Summary: the purpose of this prospective clinical study is to examine the short-term safety and efficacy of the avenue®- l interbody spinal fusion system with vertebridge® plating to treat one and two level degenerative disc disease between l2 and s1 with a focus on fusion rate.


Eligibility criteria:
inclusion criteria: * subjects must be candidates for on-label use of the avenue l device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage) * subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery * subject should have had a minimum of 6 months of non-operative treatment prior to surgery * the placement of the avenue l device must be a primary surgery * subject must be willing to sign the consent form and be able to return for all follow up visits. exclusion criteria: * subject must not have had prior surgery at the operative level(s) * subject is known to have substance or alcohol addictions * subject has lateral curvature of the spine (scoliosis, all types) * subject is a prisoner * subject is pregnant * subject has an active infection or sepsis at the time of surgery * subject has any neuromuscular disorder that would preclude accurate neurologic evaluations

Keywords: fusion lateral interbody fusion system lumbar spine degenerative disc disease
detecting abdominal aortic aneurysms in first degree relatives (adult offsprings) to aaa patients (daaad)

Conditions: Abdominal Aortic Aneurysm

Summary: the 8-12 fold higher risk for sisters and brothers of patients with abdominal aortic aneurysms (aaa) to develop aaa compared to persons in the population is well known in the scientific community. recently the value of the screening program for siblings has been analyzed and is shown to be highly cost-efficient, similar to the population based screening of 65-year old men for aaa. most importantly detection of siblings also adresses and includes women at risk. the adult offsprings to aaa patient would hypothetically bear the same risk of aaa as siblings. this has never been evaluated scientifically due to the practical difficulties in tracking the offspring and inviting them to screening at an age when they are at risk of aaa-disease. in sweden, the unique multigeneration registry exists which could support such detection, with the possibility to track adult offspring to patients, and investigate the true contemporary prevalence in them. the daaad project aims at investigating the prevalence in adult offspring parallel to developing a model for such a selective screening program

this project will evaluate four questions 1. feasibility of study design; can we evaluate the prevalence of aaa by inviting and detecting risk groups in national registries ? 2. point prevalence of aaa in a riskgroup of adult offspring to aaa patients as compared to a matched control group 3. quality of life in risk groups: measuring hads, eq-5d and questionnaire on heredity, including their awareness on their risk for aaa 4. cost-effectiveness of such a national program based on prevalence and eq-5d this program will evaluate the risk for aaa in adult offspring and also evaluate a highly probable effective registry-based detection route. this could be more cost-efficient than any other aaa screening program, since the prevalence presumably is very high, and the registry-based route could be cheaper than nurse-based detection or incidental screening. the ultimate benefit of this program will be a crude reduction of sudden deaths from aaa for adult offspring to aaa patients, and this will be specifically impressive for the female relatives that are never subjected to any aaa-screening in our country.

Eligibility criteria:
inclusion criteria: adult offspring to registered aaa parent (adult offspring) adult offspring not having a aaa parent (controls) - exclusion criteria: not living in stockholm below 45 or above 80
identification of adverse plaque characteristics by coronary mr angiography

Conditions: Coronary Artery Disease

Summary: this is a pilot study to determine whether coronary magnetic resonance angiography(cmra)can identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other substances found in the blood) seen on coronary computed tomography angiography(ccta) and evaluate whether there is a relationship between the adverse plaque characteristics and the presence of coronary artery wall inflammation.

this pilot study will examine 20 stable patients who have undergone a clinically-indicated coronary computed tomography angiography (ccta) for suspected coronary artery disease. they will be invited to undergo a research coronary magnetic resonance imaging scan with contrast(cmra). based upon the subject's heart rate, a beta blocker may be administered as its use has been shown to be effective in producing better images as it widens the arteries. researchers will use newly developed non-invasive coronary mra techniques to compare information shown on the research cmra with the clinical ccta. while ccta has been demonstrated to be able to provide data on adverse plaque characteristics (apc's), the ability of cmra to evaluate these features is not established.

Eligibility criteria:
inclusion criteria: * age ≥18 years * ability to comprehend and sign informed consent * presence of a non-calcified or mixed plaque without high-grade stenosis in the left main or a proximal coronary artery segment and at least one apc present in this plaque by ccta (defined as lap with \<30 hounsfield units or pr with ≥10% increase in the maximal vessel diameter within the plaque as compared to a proximal reference segment as previously described10). exclusion criteria: * high-grade stenosis (≥50% stenosis of the left main artery or ≥70% stenosis of another proximal coronary segment); * coronary artery stent in the segment with the reference plaque * possible pregnancy * glomerular filtration rate \<45 ml/min * more than 90 days between ccta and cmra study * any significant arrhythmia (e.g. atrial fibrillation, frequent ectopy) * significant asthma * history of 2nd or 3rd degree heart block * allergy or known intolerance to beta-blockers * use of phosphodiesterase inhibitor (e.g. viagra) within the last 48 hours * rapid heart rate (heart rate ≥90 beats/minute) * severe aortic stenosis (aortic valve area \ 30 mmhg) * systolic blood pressure \<100 mmhg * other contraindication to mri, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia

Keywords: coronary magnetic resonance angiography cmra mri with contrast multihance optimark gadolinium-based contrast mra mr angiography
efficacy of a capsular tension ring in preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome

Conditions: Cataract With Exfoliation Syndrome

Summary: the purpose of this study is to examine the efficacy of a capsular tension ring (ctr) in preventing anterior capsule shrinkage after cataract surgery in exfoliation syndrome (xfs) with no zonular weakness. the eyes with xfs undergo phacoemulsification and aspiration (pea) with an intraocular lens (iol) implantation. all operations are performed by a single surgeon. no eyes with either ectopia lentis or phacodonesis are included. there are three groups; ctr is not used in group a, ctr is simply implanted in group b, and ctr is implanted and closed by tying both eyelets in group c. the areas of continuous curvilinear capsulorhexis (ccc) are calculated, and both the time-course change and the comparison among the 3 groups are tested.


Eligibility criteria:
inclusion criteria: * eyes with exfoliation syndrome are included. exclusion criteria: * eyes with either ectopia lentis or phacodonesis are excluded.

Keywords: anterior capsule shrinkage capsular tension ring exfoliation syndrome phacoemulsification and aspiration
salivary biomarkers in pediatric traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: by studying individual biomarkers in body fluids such as saliva, there is a potential for detecting injury to the brain resulting from an acute traumatic even that may not be detectable by conventional neuroimaging like ct scans.

although identification of biomarkers following tbi is a rather novel area of research, few studies that have been done in patients with severe tbi and biomarkers from serum and cerebrospinal fluid have shown to have prognostic significance. however there are no prior studies looking at biomarkers in salivary specimens. in this study we will include patients with moderate and severe tbi who require inpatient admission, and will study 3 specific salivary biomarkers. this is a unique project, since salivary specimen collection is easy and non-invasive and can be collected at any site even on a sports field by using a simple absorbable swab resembling a cigarette stub, unlike blood or csf that can be highly invasive. salivary specimens can also be frozen and stored for long periods of time prior to testing. if our study detects abnormalities in levels of these biomarkers when compared to healthy controls, and children with extra-cerebral injuries, in future studies we can look at children and adolescents with minor head traumas and concussions who are discharged from the emergency department after evaluation, and study their long-term outcomes and correlation with salivary biomarkers. specific aims: to study levels of three specific biomarkers in salivary specimens (gfap, s100b and nse) in children with moderate tbi (gcs: 9-12) and severe tbi (gcs: \<8) admitted to a pediatric trauma referral center. these biomarkers have been shown to have prognostic significance in prior studies using serum and csf.

Eligibility criteria:
inclusion criteria: * children aged 0 to 20 who present to the pediatric ed or trauma bay with an isolated acute head injury (moderate or severe) and are admitted for inpatient management; * pediatric patients who present to the ed with non-trauma complaints; and * pediatric patients who present to the ed with non-head trauma such as musculoskeletal injuries. exclusion criteria: * patients with multisystem trauma; * patients with minor head trauma (gcs 13-15) discharged from the pediatric ed * patients with other pre-existing neurological conditions (such as cerebral palsy, chronic seizure disorder, vp shunts); * patients with a history suggestive of head trauma from chronic abuse; * incarcerated patients or patients from juvenile detention facilities; * refusal of parent/patient to participate for any specific reason.

Keywords: children head injury salivary biomarker trauma brain injury
cenobamate open-label extension study for ykp3089c025

Conditions: Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy

Summary: 52 week open-label safety study of cenobamate for subjects who complete ykp3089c025 (core study)

52 week open-label safety study of cenobamate adjunctive therapy for subjects who complete double-blind study ykp3089c025. subjects will have a 12 week double-blind conversion phase where subjects who received placebo in the double-blind study will be converted to cenobamate. subjects who received cenobamate in the double-blind study will continue to receive their daily dose of cenobamate. subjects switching from placebo to cenobamate will be titrated starting at 12.5 mg and increase their dose over the course of 12 weeks as follows 12.5 mg for 2 weeks, 25 mg for two weeks, 50 mg for two weeks, 100 mg for two weeks, 150 mg for two weeks, and 200 mg for two weeks. all subjects will receive 200 mg for the last two weeks of the conversion phase to preserve the blind. after completing the double-blind conversion phase, subjects will have 40 weeks of open-label, flexibly dosed cenobamate. the dose range is 50 mg - 200 mg. primary endpoints are all safety measures. adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight

Eligibility criteria:
inclusion criteria: * the subject must have successfully completed the double-blind treatment period in the core study. * written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the international council for harmonisation (ich) good clinical practice (gcp) guidelines. if the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. as required by country-specific regulations, only the subject may sign the icf in accordance with ich guidelines. exclusion criteria: * subject tests positive, via urine drug screen at visit 14 of the core study, for illicit drugs except for tetrahydrocannabinol and cannabinoids. * any significant changes to the subject's medical history that, in the opinion of the principal investigator, could affect the subject's safety or conduct of the study.

Keywords: idiopathic generalized epilepsy
programming cochlear implant with artificial intelligence

Conditions: Deafness; Perception

Summary: this thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. in the center of audiophonologie brussels, the classic 'manual programming' has been in use over 20 years and also the new way 'artificial intelligence programming'. the investigators want to compare, objectify, and control this new mode of programming. the study is planned over 4 years, in order to test, randomized, 15 subjects with manual programming and 15 other subjects with artificial intelligence programming. to test the performance of cochlear implant patients, audiological, language auditory perception and questionnaire tests will be presented. this research aims to determine the contribution and results of artificial intelligence programming.


Eligibility criteria:
inclusion criteria: * unilateral cochlear implant * post-lingual hearing loss * a good command of french. exclusion criteria: * non deaf * bilateral cochlear implant * deaf without cochlear implant

Keywords: deafness cochlear implant artificial intelligence