Kornimate/medical-research-clean huggingface dataset:
mepolizumab long-term study to assess real world safety and effectiveness of eosinophilic granulomatosis with polyangiitis (egpa) in japan

Conditions: Churg-Strauss Syndrome; Eosinophilic Granulomatosis With Polyangiitis

Summary: eosinophilic granulomatosis with polyangiitis (egpa), formerly known as the churg-strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. nucala® (mepolizumab 300 milligrams \[mg\], subcutaneous administration) was approved in japan in 2018 for the treatment of egpa in adult participants. this is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of nucala. approximately 120 participants who completed the nucala post marketing surveillance (pms) study (national clinical trial \[nct\]03557060) will be enrolled in the study. nucala is a registered trademark of glaxosmithkline (gsk) group of companies.


Eligibility criteria:
inclusion criteria: * adult participants with egpa of \>=20 years of age inclusive, at the time of signing the informed consent. * participants must have a current clinical diagnosis of egpa by physician. * participants have continuously used nucala for at least 96 weeks for the treatment of egpa as mentioned in the current label in japan. • participants thus were registered and completed the nucala pms study (special drug use investigation; protocol number 208505, nct03557060) prior to be enrolled in this study. * physician's decision to continue treatment with nucala for the treatment of egpa as mentioned in the current label in japan. * prior to commencing any study related activities, participants must be able and willing to provide written informed consent. exclusion criteria: * participants who have previously discontinued nucala treatment for egpa for more than 12 weeks. * participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product. * participants with any reasons that in physician's opinion would place the participants at risk. * participants who are pregnant or breastfeeding.

Keywords: nucala eosinophilic granulomatosis with polyangiitis real world setting long term safety and efficacy
medium to long term outcomes of selective dorsal rhizotomy

Conditions: Cerebral Palsy

Summary: the main purpose of this study is to investigate the medium to long-term outcomes (3-10 years) after selective dorsal rhizotomy (sdr) in ambulatory children and young people with cerebral palsy. the participants will complete a survey, come to hospital for some measurements and tests. some parents and children and young people will also be invited to take part in an interview to understand their experiences of sdr.

the aim of this study is to investigate medium (3-5 years) to long-term (6-10 years) outcomes after sdr surgery in ambulatory children with cp and explore how it affects families' (cyp's and parents') lives over time. a convergent parallel mixed methods study has been designed across two work packages (wps), which will run in parallel. the international classification of functioning, disability and health (icf) will be used as a theoretical framework to guide the data collection and to integrate data from each wp. wp-1 is an observational cohort study and wp-2 is a qualitative study. in the observational cohort study (wp-1), routinely collected standardised outcome measures will be repeated at one additional time point, more than three years after surgery. this will mirror previous assessments carried out as part of the sdr clinical pathway, which normally concludes two years after surgery. a survey including validated patient reported outcome measures (proms) and a study-specific questionnaire will also be administered in wp-1. the qualitative study (wp-2) will involve an in-depth exploration of parents' and cyps' views through semi-structured interviews to explore parents' and cyps' experiences, reflections, and perceptions of outcomes and satisfaction of sdr in relation to previous expectations. the results from the two wps will be combined by comparing and contrasting findings from both wps to provide a more holistic understanding and gain deeper insights into longer-term sdr outcomes. findings will be used to create evidence-based family resources and decision aids to help families decide whether sdr surgery is the right treatment choice for the child and support their preparation and adjustments after sdr.

Eligibility criteria:
inclusion criteria: * children and young people with cerebral palsy (cypwcp) * classified as gmfcs level ii and iii (ambulatory) * aged between 2-15 years at the time of surgery * underwent sdr surgery at great ormond street hospital for children (gosh) (between 2013- 2021) * had baseline (pre-surgery) assessment and at least one follow-up assessment at 6, 12 or 24 months post-sdr parents of cyp with cp who have undergone sdr surgery (and meet the above criteria for cyp) exclusion criteria: * children with cp classified as gmfcs level iv, v (non-ambulatory) * have any unrelated musculoskeletal problems, such as a recent acute injury

Keywords: selective dorsal rhizotomy rehabilitation physiotherapy
comparison of brachial wrist index before and after implantation of arteriovenous fistulas, based on brachial artery

Conditions: Vascular Access Complication

Summary: arterio-venous fistula (avf) is the most recommended vascular access for hemodialysis. steal syndrome is a potential complication of avf implantation and occurs secondary to diversion of the arterial flow of a limb to the venous system resulting in limb ischemia. measuring wrist pressure compared to arm pressure before and after fistula implantation can be a suitable tool in predicting the possibility of steal syndrome. in this study, the ratio of wrist to arm pressure and its relationship with steal syndrome symptoms before and after fistula implantation are investigated.

chronic kidney disease (ckd) affects the structure and function of the kidneys. many of ckd patients are not suitable candidates for a kidney transplant, so relying on some type of dyalisis is unavoidable. hemodialysis is the most common type of renal replacement therapy. the best vascular access for hemodialysis in patients with chronic renal failure is arterio-venous fistula (avf). one of the complications of arterio-venous fistula is steal syndrome which is ischemia of the limb secondary to blood flow diversion from the arterial system to the venous system through avf. non-invasive wrist blood pressure measurement before and after the fistula construction may accurately assess the risk of ischemia and steal syndrome from a functional avf. wrist-brachial index as a reliable prognostic test could be done easily in time of fistula construction and if it is normal, it assures the surgeon that the distal circulation is sufficient. summary of the project implementation method: first, the demographic questionnaire is completed for patients who meet the criteria for entering the study. then the wrist-brachial index of patients who are candidates for fistula implantation before and after the fistula implantation is measured. two weeks and three months later (times of suture removal and fistula maturation assessment), the measurements are repeated and their correlations with steal syndrome symptoms are recorded. the data will be analyzed in spss16 statistical software

Eligibility criteria:
inclusion criteria: * esrd patient candidate for hemodialysis * eligible for avf implantation * cardiac ejection fraction \> 20% * age\> 18 years * suitable brachial artery and superficial vein for avf exclusion criteria: * death * non-consent of the patient * failure to follow up * fistula failure

Keywords: hemodialysis arterio venous fistula steal syndrome wrist-brachial index vascular access
zoledronic acid to prevent bone loss after kidney transplantation

Conditions: Renal Osteodystrophy

Summary: the purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

for the treatment of osteoporosis in the general population, a number of drugs reduce bmd (bone mineral density) loss and the rate of incident fractures. for instance, bisphosphonates improve bmd, reduce hip fracture rates and decrease mortality in post-menopausal women. because of lack of data on safety and an increased risk of adverse effects, the use of these drugs is controversial in patients with chronic kidney disease (ckd) and abnormalities of pth or vitamin d, an estimated glomerular filtration rate (gfr) less than 30 ml/min/1.73m² (ckd stages 4 and 5) and after transplantation. the efficacy of short and long term bisphosphonate treatment after kidney transplantation has been examined; however, histomorphometric and fracture rate reduction data are lacking. the purpose of this study is to determine whether zolendronic acid, a third generation bisphosphonate, is effective in preventing bone loss in the first year after kidney transplantation.

Eligibility criteria:
inclusion criteria: * all adult kidney transplant recipients who were stable perioperative and able to return for regular follow-up exclusion criteria: * glomerular filtration rate \< 30 ml/min/1.73m² one week after transplantation * previous parathyroidectomy or diagnosis of adynamic bone disease (with bone biopsy)

Keywords: bone disease kidney transplantation bisphosphonates
a multicenter, open-label, phase 1b study of carfilzomib, cyclophosphamide and dexamethasone in newly diagnosed multiple myeloma subjects

Conditions: Multiple Myeloma

Summary: the primary objective was to determine the maximum tolerated dose of carfilzomib given twice weekly in combination with cyclophosphamide and dexamethasone for patients with newly diagnosed multiple myeloma.


Eligibility criteria:
inclusion criteria: 1. newly diagnosed multiple myeloma 2. measurable disease, as defined by 1 or more of the following * serum m-protein ≥ 0.5 g/dl, or * urine m-protein ≥ 200 mg/24 hours, or * in subjects without detectable serum or urine m-protein, serum free light chain (sflc) \> 100 mg/l (involved light chain) and an abnormal kappa lambda ( κ/λ) ratio 3. males and females ≥ 18 years of age 4. eastern cooperative oncology group (ecog) performance status 0-2 5. adequate hepatic function 6. left ventricular ejection fraction (lvef) ≥ 40% 7. absolute neutrophil count (anc) ≥ 1.0 × 10\^9/l 8. platelet count ≥ 50 × 10\^9/l 9. calculated or measured creatinine clearance (crcl) of ≥ 15 ml/min exclusion criteria: 1. planned autologous hematopoietic stem cell transplantation (hsct) for the initial therapy of newly diagnosed multiple myeloma 2. multiple myeloma of immunoglobulin m (igm) subtype 3. prior systemic treatment for multiple myeloma 4. glucocorticoid therapy within 14 days prior to enrollment that equals or exceeds the equivalent of dexamethasone 160 mg 5. known amyloidosis 6. active congestive heart failure (new york heart association \[nyha\] class iii to iv), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. myocardial infarction within 6 months prior to enrollment. 7. known human immunodeficiency virus (hiv) seropositive, hepatitis c infection, and/or hepatitis b (subjects with hepatitis b surface antigen \[sag\] or core antibody receiving and responding to antiviral therapy directed at hepatitis b are allowed) 8. significant neuropathy (grades ≥ 2) within 14 days prior to enrollment 9. any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent

Keywords: multiple myeloma
lisa-study : levothyroxin in nodular goiter

Conditions: Goiter, Nodular

Summary: primary objective: * to evaluate change in total volume of all nodules. secondary objectives: * to evaluate change in goiter volume after a 12-months treatment, number of nodules and echogenicity of nodules.


Eligibility criteria:
inclusion criteria: * caucasian * normal tsh value (target range between 0.6 - 3.0 mu/l) * thyroid nodules in a normal sized or enlarged thyroid at least one nodule (smaller/equal 20 % of volume with cystic change) with greater/equal 1.0 cm diameter, for nodules greater 1.0 cm the diagnosis must be performed according to the guideline for diagnostic standards of thyroid disorders. exclusion criteria: * thyroid therapy within the last 3 years * known focal or diffuse structure autonomous thyroid * contraindication to iodine * concomitant treatment with iodine containing medication (i.e. amiodarone) * use of iodine-containing contrast medium within the last 6 weeks * presence of tpo antibodies (maximum two fold normal value) * symptomatic coronary heart disease * endocrine orbitopathy * known autoimmune thyreopathy * former radioiodine therapy or surgery * dermatitis herpetiformis * pathological laboratory results * participation in another clinical study with investigational medication within the last 30 days * pregnant or nursing female patients * female patients of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/hysterectomized or who are not using any other method considered sufficiently reliable by the investigator in individual cases. * severe or unstable cardiovascular diseases (e.g. severe angina pectoris, postmyocardial infarction syndrome and ventricular extrasystoles, symptomatic coronary heart disease), clinically relevant renal or hepatic diseases or disorders, any other clinically relevant condition that might enhance the risk for the study participant. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
cmsl ambulatory sensitive condition nudge

Conditions: Behavioral Intervention; Emergency Department Visits; Nurse Care Coordination

Summary: the project aims to evaluate a nurse-led intervention to reduce inappropriate emergency department (ed) use among adult patients seen at geisinger's community medicine service line (cmsl) clinics. the intervention occurs immediately following an appointment where they received a diagnosis of an ambulatory sensitive condition (asc). the evaluation will compare eligible patients with an asc who were randomly assigned to receive follow-up outreach from a nurse (who was automatically prompted via the epic electronic health record system to initiate outreach) with those who were randomly assigned to receive standard care. analyses will be intent-to-treat. the primary outcome is ed use in the week following the appointment.


Eligibility criteria:
inclusion criteria: * age 18 years + * has a visit in cmsl with an ambulatory sensitive condition (asc) encounter diagnosis

Keywords: nudge
mr guided focused ultrasound treatment of uterine fibroids with enhanced sonication

Conditions: Uterine Leiomyoma; Uterine Fibroids

Summary: this is a phase 3 study to determine the safety of the new features to the fda approved exablate device using a new method to ablate fibroids deemed enhanced sonication.

uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. these benign tumors are generally oval in shape, and often highly vascular. on t2 weighted mr imaging exams, or t1 exams with contrast, uterine fibroids are easily identifiable. they occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. insightec has developed an enhanced sonication (es) technique for the ablation of these fibroids. this mode of tissue ablation has been added to the already fda approved exablate system. the goal of this es technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving all clinical features of the current commercially approved version.

Eligibility criteria:
inclusion criteria: 1. women age 18 or older, who present with symptomatic fibroids 2. women who have given written informed consent 3. women who are able and willing to attend all study visits. 4. patient is pre or peri-menopausal (within 12 months of last menstrual period). 5. able to communicate sensations during the exablate procedure. 6. uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). 7. fibroids(s) clearly visible on non-contrast mri. exclusion criteria: 1. women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment 2. patient who desire to become pregnant in the future. 3. patients who are breast-feeding. 4. patients with an active pelvic inflammatory disease (pid) 5. active local or systemic infection 6. metallic implants that are incompatible with mri 7. known intolerance to the mri contrast agent (e.g. gadolinium or magnevist) 8. severe claustrophobia that would prevent completion of procedure in the mr unit. 9. extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path. 10. known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia. 11. pedunculated fibroids. 12. intrauterine device (iud) anywhere in the treatment path 13. undiagnosed vaginal bleeding.

Keywords: fibroids leiomyoma neoplasm benign tumors
methylprednisolone during the switch between natalizumab and fingolimod

Conditions: Multiple Sclerosis

Summary: progressive multifocal leukoencephalopathy (pml) is the most feared complication when natalizumab (ntz) is used in the treatment of relapsing multiple sclerosis (ms). the risk of pml increases after 18 months of treatment. when switching from ntz to another disease modifying treatment (dmt) in these ms patients with an active disease, there is a high risk of inflammatory reactivation. nonetheless, a washout period of several weeks is necessary before initiating a new dmt. the primary purpose of this protocol is to investigate the impact of high dose of oral methylprednisolone, given once a month during the washout period between ntz and fingolimod (fty).

patients with ms receiving ntz for at least 18 months and without any disease activity during the previous year will be eligible. included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo. every patient will initiate a treatment with fty 7 weeks after the last ntz perfusion. methylprednisolone or placebo will be taken 4, 8 and 12 weeks (w4, w8 and w12) after ntz discontinuation. a spinal and brain mri will be performed at baseline (last ntz perfusion, noted w0) and 16 to 18 weeks after. the last clinical follow-up will be made after 24 weeks.

Eligibility criteria:
inclusion criteria: * relapsing-remitting multiple sclerosis (mc donald's 2010 criteria) * edss\<6.0 * at least18 natalizumab infusions * planned switch from natalizumab to fingolimod * aged between 18 and 65 * patients must have received high dose iv methylprednisolone during the 5 previous years exclusion criteria: * progressive ms * uncontrolled ms with natalizumab (existence of a relapse during the previous 12 months or existence of a gadolinium enhancing lesion on a mri performed during the last 12 months) * sep de forme progressive * contra-indication to the use of high dose oral methylprednisolone * marked cognitive impairment altering protocole understanding * switch from natalizumab to a disease modifying treatment different from fingolimod * contra-indication to fingolimod use * existence of a disease or condition that could alter study completion * chronic treatment with steroids * acute treatment with steroids (more than 300mg during the month prior to inclusion) * contra-indication to gadolinium containing products injection * pregnancy

Keywords: multiple sclerosis natalizumab fingolimod methylprednisolone
comparing diabetes prevention programs

Conditions: Pre Diabetes; Diabetes

Summary: the purpose of this study is to compare the effectiveness and costs of two programs,the diabetes prevention program and the community-developed healthy living program, delivered in an primary care practice.


Eligibility criteria:
inclusion criteria: * at least 18 years old * diagnosed with pre-diabetes exclusion criteria: * diagnosed with diabetes * pregnant or nursing * unable to walk 2-3 blocks in 10 minutes * unable to read and speak english
assessment of myocardial ischemic-reperfusion injury during off- and on- pump cabg

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Ischemic Reperfusion Injury; CABG

Summary: assessment of myocardial ischemic-reperfusion injury during off- and on- pump cabg.

assessment of myocardial ischemic-reperfusion injury during off- and on- pump cabg is monitored by intraoperative measurement of serum level of myeloperoxidase before sternotomy and after sternal closure.

Eligibility criteria:
inclusion criteria: * ischemic heart disease exclusion criteria: * valve disease * diabetes millitus

Keywords: cabg off-pump cabg on-pump cabg ischemic-reperfusion injury during cabg comparison of on- and off- pump cabg ischemic heart disease myocardial ischemia-reperfusion and myeloperoxidase myocardial ischemia-reperfusion biomarkers