Kornimate/medical-research-clean huggingface dataset:
aprepitant for the prevention of chemotherapy induced nausea and vomiting (cinv)(0869-130)(completed)

Conditions: Chemotherapy-Induced Nausea and Vomiting

Summary: the study will test aprepitant for the prevention of cinv in patients receiving their initial cycle of moderately emetogenic chemotherapy (mec). patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an iv formulation of aprepitant will be given in place of the oral formulation on study day one. study drug administration on subsequent days will be given orally as in cycle 1.


Eligibility criteria:
inclusion criteria: * patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1 * karnofsky score of 60 or greater exclusion criteria: * patient is scheduled to receive any dose of cisplatin * patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy * any allergies to study drug or antiemetics * taking cyp3a4 substrates/prohibited medication * significant medical or mental conditions * abnormal laboratory values (platelets, absolute neutrophils, ast, alt, bilirubin or creatinine).
canakinumab study in individuals with newly diagnosed type 1 diabetes

Conditions: Type 1 Diabetes; Preservation of Insulin Secretion; Newly Diagnosed Type 1 Diabetes; Canakinumab in Type 1 Diabetes

Summary: canakinumab is a fully human anti-interleukin-1β (anti-il-1β) monoclonal antibody (igg-1 class). canakinumab is designed to bind to human il-1β and to functionally neutralize the bioactivity of this pro-inflammatory cytokine. the study is a two-arm, multicenter, randomized, double-masked, placebo-controlled clinical trial. 66 subjects will be randomly assigned to receive either monthly subcutaneous injections of 2.0 mg/kg canakinumab, or placebo for 12 months. all groups will receive standard intensive diabetes treatment with insulin and dietary management. participants randomly assigned to canakinumab treatment or placebo will receive a total of 12 injections over one year. all subjects will be followed for 1 year of treatment plus 1- 3 years of additional follow-up until study end. enrollment is expected to occur over two years.


Eligibility criteria:
inclusion criteria: * between the ages of 6-45 years * be within 3-months (100 days) of diagnosis of type 1 diabetes * must have at least one diabetes-related autoantibody present * must have stimulated c-peptide levels \>0.2 pmol/ml measured during a mixed meal tolerance test (mmtt) conducted at least 21 days from diagnosis and within 37 days of randomization * if participant is female with reproductive potential, she must be willing to avoid pregnancy and have a negative pregnancy test during the 12 months of treatment and for an additional 3 months after completing treatment * be at least one month from time of last live immunization received * willing to forgo live vaccinations for 24 months * must be willing to comply with intensive diabetes management * must weigh at least 20 kg (44 lbs) at study entry exclusion criteria: * are immunodeficient or have clinically significant chronic lymphopenia (low white blood cell count) * have an active infection * have a positive ppd test result * be currently pregnant or lactating, or anticipate getting pregnant * ongoing use of medications known to influence glucose tolerance * require use of other immunosuppressive agents * have serologic evidence of current or past hiv, hepatitis b, or hepatitis c infection * have any complicating medical issues or abnormal clinical laboratory blood counts or results that interfere with study conduct; history of malignancies * be currently participating in another type 1 diabetes treatment study

Keywords: type 1 diabetes newly diagnosed t1d t1d canakinumab anti il-1
origin of cec in patients after allo-hsct

Conditions: Graft Versus Host Disease, Acute; Endothelial Dysfunction; Immune Tolerance

Summary: we believe that cec, besides coming from cells shedding from patient vasculature, could partly belong to donor, originating from the cellular graft.

in consideration of the fact that the vascular endothelium has been shown to be a target of gvhd in early stage and that the count of cec represent a marker of endothelial damage, we want to correlate the presence of donor cec at engraftment with a putative protective function against gvhd manifestations. we will enroll patients affected by hematologic disorders undergoing allo-hsct. at time of engraftment and at + 3 months after allo-hsct, cec identified and counted by means of the cellsearch system, will be recovered from the counting cartridge and further sorted at the single cell level. str profile of each single cec recovered will be performed in order to define host versus donor origin of each cec analysed. through the conduct of this study, we expect to upfront identify patients who will or will not manifest gvhd. this result will allow definitely different clinical approaches: stringent monitoring and early therapeutic intervention, before refractory disease's development, in the formers, while, sparing unnecessarily expensive testing or heavier treatment in the latters.

Eligibility criteria:
inclusion criteria: * patients undergoing allo-hsct for their neoplastic hematologic diseases * written informed consent * achievement of hematopoietic recovery from aplasia post-allo-hsct * predictable life expectancy \> 6 months exclusion criteria: * presence of active malignant hematologic disease at time of allo-hsct

Keywords: circulating endothelial cells graft versus host disease neovascularization allotransplantation
evaluation of postoperative pain following bascom cleft lift operation

Conditions: Postoperative Pain

Summary: the purpose of this study is to evaluate postoperative pain in bascom cleft lift operation receiving multimodal analgesia in day-case surgery setting. hypothesis: multimodal analgesia provides adequate pain relief in patients undergoing bascom cleft lift operation.


Eligibility criteria:
inclusion criteria: * age \> 18 * asa physical status 1 and 2 * patient undergoing bascom operation in prone position exclusion criteria: * pregnancy * current regular use of drug belonging to the class of opioids * allergy/ intolerance to drugs included in multimodal analgesia regime

Keywords: postoperative pain multimodal analgesia bascom cleft lift day-case.
clinical outcomes of use of olaparib in castration resistant prostate cancer

Conditions: Prostate Cancer; Castrate Resistant Prostate Cancer; BRCA Mutation

Summary: this is an observational, retrospective/prospective, multicenter study designed to define, overall survival, clinical outcomes and predictive/prognostic factors of a consecutive population of mcrpc patients treated with olaparib in clinical practice.


Eligibility criteria:
inclusion criteria: brca mutant metastatic castration-resistant prostate cancer patients treatment with olaparib in clinical practice exclusion criteria: olaparib treatment in a clinical trial
safety of diamyd® in patients with lada (latent autoimmune diabetes in adult)

Conditions: Latent Autoimmune Diabetes in Adult (LADA)

Summary: this is a study to investigate the safety of 20ug diamyd® (rhgad65 formulated in alhydrogel®), administered subcutaneously four weeks apart in patients with latent autoimmune diabetes in adult (lada).


Eligibility criteria:
key inclusion criteria: * male and female patients between 30-70 years of age diagnosed with type 2 diabetes within 5 years * presence of gad65 antibodies * detectable c-peptide level * patients requiring treatment with diet and/or oral hypoglycaemic agents (oha) * written informed consent key exclusion criteria: * treatment with insulin * intolerance to oha * secondary diabetes mellitus * history of certain diseases or conditions (e.g. anaemia, epilepsy, head trauma, neurological disease, alcohol or drug abuse, hiv, hepatitis) * treatment with any vaccine within one month prior to first diamyd® dose or planned treatment with vaccine up to 2 months after the second diamyd® dose * participation in other clinical trials with a new chemical entity within the previous 3 months * pregnancy (or planned pregnancy within one year after 2nd administration) * presence of associated serious disease or condition which in the opinion of the investigator makes the patient non-eligible for the study * significant illness other than diabetes within 2 weeks prior to first dosing * unwillingness to comply with the provisions of the protocol * clinically significant history of acute reaction to drugs in the past * treatment with immunosuppressants

Keywords: type 2 diabetes lada latent autoimmune diabetes in adult autoimmunity hba1c c-peptide
dextenza vs prednisolone acetate after cataract surgery for patients with diabetes

Conditions: Cataract Diabetic; Macula Edema

Summary: this study aims to compare the effectiveness of dextenza vs standard of care prednisolone taper after cataract surgery in diabetic patients with regards to controlling post-op inflammation at post-op days 7, 14, and 30.

the inflammation after cataract surgery is controlled at the investigators' institution by a taper of prednisolone acetate 1%, which consists of four drops daily for one week, followed by three drops daily for one week, then two drops daily for one week, then one drop daily for one week. due to the frequency of drops needed after cataract surgery, compliance with the post-op regimen often wavers. this study aims to evaluate the efficacy of dextenza, which has been shown to be better than placebo after cataract surgery (1), against prednisolone acetate taper. if shown to be as effective without compromising safety, it could be a very convenient alternative to prednisolone acetate taper. furthermore, if dextenza is shown to be as effective as prednisolone taper in diabetic patients, it could be logically generalized that it would be effective in patients without diabetes as well, as patients without diabetes (and with no confounding risk factors, such as a history of uveitis) are less prone to developing post-op macular edema. risks are minimal for this fda approved treatment and include iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). these risks are comparable to prednisolone acetate.

Eligibility criteria:
inclusion criteria: * patients with diagnosed diabetes * patients must be undergoing cataract surgery in each eye * patients must have no worse than moderate nonproliferative diabetic retinopathy exclusion criteria: * patients must not have any history of documented macular edema on oct * patients must not have any macular edema on pre-op oct * patients must not have any history of uveitis * patients must not have severe nonproliferative or proliferative diabetic retinopathy * patients with operative complications will be excluded from this study * patients with any active corneal disease, infectious or rheumatologic, will be excluded * patients must not be pregnant

Keywords: prednisolone dextenza
comparison of physical fitness, walking speed, reaction time in older adults with and without mild cognitive impairment

Conditions: Reaction Time; Physical Fitness

Summary: the aim of the study is to compare physical fitness, walking speed and hand reaction time measurements in older adults with different cognition levels according to the montreal cognitive assessment scale (moca).


Eligibility criteria:
inclusion criteria: * being 65 years or older * volunteering to participate in the study * 10 meters independent walking * being diagnosed with mild cognitive dysfunction * not being diagnosed with cognitive dysfunction * having received five years of basic education exclusion criteria: * having had an upper or lower extremity surgery in the last 6 months * having a health problem that prevents completing the tests in the study
enhancing psychological self-help with implementation intentions

Conditions: Social Anxiety

Summary: individuals with visible conditions often report experiencing lowered social confidence and encountering intrusive reactions from others, yet relatively few targeted psychosocial self help interventions are available. the investigators will conduct a randomised controlled trial to compare the efficacy of an adapted form of an existing self-help intervention with an enhanced version of the same intervention that incorporates if-then planning instructions (or 'implementation intentions') and a control condition that will receive support as usual. participants who self-identify as having a visible condition affecting the skin or hair, or scarring to the skin that negatively affects their social confidence will be allocated to one of three conditions: augmented self-help, standard self help or control. the interventions will be delivered online and participants will complete psychometric outcome measures at two time points, four weeks apart. it is hypothesised that participants who receive the augmented self help intervention will have a statistically significant decrease in fear of negative evaluation in comparison to both the standard self-help and support as usual control groups.

the proposed research will take the form of a randomised controlled trial conducted in accordance with consort guidelines (http://www.consort-statement.org). data will be collected online using qualtrics. participants will be required to answer all fields on qualtrics, as a way of managing potential missing data. participants will be randomly allocated to one of three groups: (i) psychological self-help augmented with implementation intentions, (ii) standard psychological self-help or (iii) a no intervention waiting list control. qualtrics will be used to randomly allocate participants to one of the three groups. a sample size analysis has been conducted and calculated assuming two measures, three groups, an alpha of 0.05, a power of 0.8, and an effect size of 0.25; a total sample size of 120 participants would be needed (i.e. 40 per group). allowing for an attrition rate of 20%, 144 participants would need to be recruited (i.e. 48 per group). although participants will be randomised to condition, it is best practice for any differences at baseline to be controlled for in analyses and thus a between factors repeated measure analysis of variance (anova) will be conducted.

Eligibility criteria:
inclusion criteria: * participants self-identify as having a visible skin difference * participants will be aged 18 years or over * participants will be fluent in the english language exclusion criteria: participants will be excluded if they are currently receiving psychotherapy

Keywords: health behaviour change implementation intention if then plan skin condition visible difference self help
tasall - tachosil® against liquor leak

Conditions: Cerebrospinal Fluid Leaks

Summary: the primary objective is to demonstrate superiority of tachosil® compared to current practice as an adjunct in sealing the dura mater. the efficacy of the dura mater sealing must be evaluated post-operatively. the secondary objective is to evaluate the safety of tachosil® as an adjunct in sealing the dura mater. the trial population will consist of 726 randomised (1:1) patients elected for skull base surgery. the trial duration consists of screening, surgery, efficacy follow-up after 7±1 weeks and safety follow-up 28±2 weeks after surgery.


Eligibility criteria:
main inclusion criteria (positive response): • is the surgical approach/procedure consistent with skull base surgery? i.e. one of the following: * lateral approach to the foramen magnum: far lateral, extreme lateral, anterolateral, posterolateral * approach to the jugular foramen: infratemporal, juxta condylar, transjugular * approach to the cerebello pontine (cp) angle and petrous apex retrosigmoid * approach to the middle fossa: subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition) * approach to the anterior fossa: subfrontal (uni or bilateral) * approach to the midline posterior fossa main exclusion criteria (negative response): * has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months? * is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the efficacy follow-up week 7±1 week? * is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the safety follow-up week 28±2 weeks? * the surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial - transfacial approaches with wide defect in the skull base? i.e. any of the following: * trans basal approach * total petrosectomy * trans facial approach * trans sphenoidal approach * endoscopic procedures * trans oral approach (and any extension: le fort, mandibulotomy) * the surgical approach is consistent with one of the following approaches? * translabyrinthine approach * retrolabyrinthine approach * transcochlear (limited transpetrosal) approach * did the arachnoid membrane and the csf containing system remain intact during surgery? * does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)? * has tachosil, fibrin or polymer sealants been used during the current surgery prior to randomization?

Keywords: csf leaks skull base surgery pseudomeningocele tachosil® prevention post-operative
long term special drug use-results surveillance for mayzent in spms patients

Conditions: Secondary Progressive Multiple Sclerosis (SPMS)

Summary: this study is a single cohort, central registration system, all-case, open-label, multicenter observational study in patients using mayzent for the indication of secondary progressive multiple sclerosis.

this is a non-interventional study, and as such there is no binding treatment strategy, diagnosis/treatment procedures or visit schedule. the investigator should administer mayzent as labelled. routine medical practice will apply to visit frequency and evaluation variables, and only these data will be collected by the sponsor as part of the study procedures. the investigator should record data in the applicable crfs at every visit if possible.

Eligibility criteria:
inclusion criteria: * patients prescribed mayzent for prevention of relapses and delay of progression of physical disability in secondary progressive multiple sclerosis exclusion criteria: -

Keywords: secondary progressive multiple sclerosis spms mayzent siponimod japan
ferritin screening and iron treatment for maternal anemia and fgr prevention trial

Conditions: Iron Deficiency (Without Anemia); Pregnancy Related

Summary: prevalence of anemia in asia is more than 50%. all woman who book for antenatal care with non-anaemic iron deficiency (naid) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. the investigators will compare this intervention with usual care in a multicentre randomised trial.

prevalence of anemia (haemoglobin less than 11 gm/dl) in asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or naid is likely to be more prevalent than this figure. it has been hypothesised that naid in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. the investigators will compare, in naid, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.

Eligibility criteria:
inclusion criteria: * non-anaemic iron deficiency exclusion criteria: * anaemia or normal iron stores

Keywords: anemia, ferritin
mister parkinson: educational therapy in parkinson's disease (pd)

Conditions: Parkinson Disease

Summary: parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. these can contribute to the burden of the disease on patients and their caregivers, and often remain unrecognized and untreated. this was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care.

parkinson's disease is multidimensional disorders characterized by motor and non-motor symptoms such as behavioral and psychological symptoms, autonomic disturbances and other non-motor symptoms. a multidisciplinary and comprehensive approach, based on the chronic care model, is considered the best way to manage motor and non-motor symptoms of the disease, although this model of care is still not standardized and previous trials showed conflicting results. the study planned to enrol 40 advanced pd patients and related caregivers for each investigational site. this was a single-blind,multicentric, prospective, randomized study comparing two arms: an intervention group undergoing a structured educational program associated to standard care and a control group who solely continued with traditional medical care. the educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease (according to uk brain bank criteria) * being aged 20-80 years * being able to complete questionnaires * having no severe cognitive impairment (mini-mental state examination ≥24) * having a stable caregiver exclusion criteria: * atypical parkinsonian * severe comorbidity significantly interfering with quality of life

Keywords: parkinson disease burden caregiver educational program