Kornimate/medical-research-clean huggingface dataset:
atacicept phase 2/3 in generalized systemic lupus erythematosus (april-sle)

Conditions: Lupus Erythematosus, Systemic

Summary: this study is to evaluate the efficacy and safety of atacicept compared to placebo in preventing new flares in subjects with systemic lupus erythematosus (sle) and to confirm the optimal dose of atacicept for treatment of subjects with sle and gain information on the effect of atacicept on markers specific to its mechanism of action (moa) and their correlation to disease activity/progression. study medication will be administered through subcutaneous (under the skin) injections, beginning with twice weekly injections for the first 4 weeks, followed by once weekly doses for 48 weeks. following the last treatment, a safety follow-up period of 24 weeks will be conducted.


Eligibility criteria:
inclusion criteria: * male or female 16 years of age or older * disease history of at least six months meeting at least 4 out of the 11 american college of rheumatology (acr) criteria for sle * active sle with at least one british isles lupus assessment group (bilag) flare a or b at screening requiring a change in the dose of corticosteroids * positive antinuclear antibody (ana) or anti-double-stranded deoxyribonucleic acid (dsdna) at screening * female subjects must be willing to avoid pregnancy by using an adequate method of contraception for 4 weeks prior to study day 1, during the trial and 24 weeks after the last dose of study medication * other protocol defined inclusion criteria could apply exclusion criteria: * active moderate to severe glomerulonephritis (kidney impairment) as defined in the protocol * active central nervous system sle deemed to be severe/progressive and/or associated with significant cognitive impairment leading to inability to provide informed consent and/or comply with the protocol * previous treatment with rituximab, abatacept, or belimumab * history of demyelinating disease such as multiple sclerosis (ms) or optic neuritis * other protocol defined exclusion criteria could apply

Keywords: atacicept 75 and 150 mg placebo
effect of topical botulinum toxin eyedrop on palpebral fissure

Conditions: Tears; Excess; Eyelid Spasm

Summary: the purpose of this research study is to test if topical (applied to the surface of the eye) botulinum toxin temporarily lowers the upper eyelid and makes the eyelid appear less open and thereby affects the eye surface and decreases reflexive tearing.


Eligibility criteria:
inclusion criteria: * adults aged 18 and above that present to the oculoplastic and reconstructive surgery department that are able to provide informed consent to participate * presence of upper eyelid retraction or asymmetry( \>1mm) exclusion criteria: * adults unable to consent * individuals less than 18 years of age * prisoners * pregnant women. o patients will be asked if they are pregnant by research staff before participation in the study. women who are breast-feeding * known contradictions or sensitivities to study medication * grossly abnormal lid margins, anatomical abnormalities * variable ptosis or eyelid position (e.g., myasthenia gravis, blepharospasm) * any ocular or systemic condition that, in the opinion of the investigator, would confound study data, interfere with the subject's study participation, or affected the subject's safety or trial parameters * presence of an active ocular infection * inability to sit comfortably for 15 - 30 minutes * botulinum toxin injection in the eyelids during the past 3 weeks. * neuromuscular disorders (e.g., parkinson's disease or myasthenia gravis) * medication use known to interfere with the effects of botulinum toxin-a within the previous 1 month (e.g., aminoglycoside or benzodiazepines), * previous history of hypersensitivity reactions to botulinum toxin-a * dysfunction of tear production or secretion (e.g., meibomian gland dysfunction or sjogren's syndrome),
revlimid, endoxan, prednison evaluation after prior revlimid treatment (repeat)

Conditions: Multiple Myeloma

Summary: study phase: phase 1 and phase 2 objective: evaluation of the effect of lenalidomide, cyclophophamide and prednisone (rep) in patients with relapsed multiple myeloma previously treated with lenalidomide study design: prospective, multicenter, non-randomized

the repeat-study is a prospective, multicenter, non-randomized phase 1 and phase 2 study in which we evaluate the effect of lenalidomide, cyclophosphamide and prednisone (rep-therapy) in patients with relapsed multiple myeloma, previously treated with lenalidomide and refractory to lenalidomide monotherapy.

Eligibility criteria:
inclusion criteria: * salmon \& durie stage ii/iii a or b * previous lenalidomide refractory disease * patient commits to pregnancy prevention programme exclusion criteria: * non-secretory myeloma * known hypersensitivity to lenalidomide * inadequate marrow reserve

Keywords: repeat multiple myeloma revlimid lenalidomide cyclophosphamide endoxan prednisone lenalidomide refractory
use of campath for induction and maintenance therapy in pancreas after kidney transplantation

Conditions: Diabetes Mellitus

Summary: this is a single center, prospective, open-label, randomized trial at the university of minnesota medical center,fairview. primary objectives are to determine if rejection episodes and loss rates, graft survival, level of renal graft function, and patient survival rates with a campath/mmf-based (group 1) immunosuppressive protocol are lower than, or equal to, our protocol using thymoglobulin, tacrolimus, and mmf (group 2). this study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients.

secondary objectives of the study are: 1. compare the side effects of the immunosuppressive medications between both groups. this will include anaphylactic reactions, gi side-effects, bone marrow suppression, renal dysfunction, hypertension, hyperglycemic effects, and effects on lipid profile. 2. compare the incidence of infections between both groups. comparison parameters are: 1. pancreas and kidney graft failure 2. patient death 3. clinical and biopsy documented rejection episodes 4. patient dropout (non-compliance with the study protocol) 5. kidney function as assessed by creatinine clearance or biopsy 6. need to change immunosuppression regimen 7. quality-adjusted life years

Eligibility criteria:
inclusion criteria: 1. previous kidney transplant from a living or deceased donor and a deceased- donor pancreas transplant. 2. recipient age 18-60 years 3. donor age 10-59 years 4. females of childbearing potential should have a negative pregnancy test, and agree to practice birth control for the duration of the study. 5. enteric or bladder drained pancreas transplant. - exclusion criteria: 1. use of an investigational drug in the last 1-year. 2. positive t or b cell crossmatch. 3. wbc\<3000 at enrollment 4. platelet count \<50,000 at enrollment 5. history of malignancy (exclusive of minor skin cancers) 6. inability to give informed consent 7. systemic infections 8. major active or chronic infections, including documented hiv infection (by any licensed elisa and confirmation by western blot). 9. serology negative for ebv pre-transplant. 10. no other previous organ transplants other than pancreas and/or kidney. -

Keywords: campath study pancreas after kidney transplantation alemtuzumab
modified brostrӧm procedure with and without possible arthroscopy for lateral ankle instability

Conditions: Lateral Ankle Instability

Summary: this study is to show that the investigators believe the modified brostrӧm procedure (mbp) can be completed without a routine ankle arthroscopy. routine ankle arthroscopy, if determined not to be necessary in all cases, is a waste of resources in terms of operating room, surgeon, and staff time as well causing an increase in hospital financial expenses. most importantly, this procedure is morbid. ankle arthroscopy forces a patient's foot into distraction for up to one hour, exposes the patient to potentially longer anesthesia exposure that is unnecessary, increases infectious risks, and requires exposure at the portal sites near superficial nerves.

the purpose of this investigation is to determine if ankle arthroscopy is necessary in the treatment of routine ankle instability without evidence of intra-articular pathology on mri. our study population will include those individuals whose ankle mri is inconclusive or negative for intra-articular pathologies, and intra-articular ankle pain is not a predominant presenting symptom. although it is our current practice at wbamc not to conduct an ankle arthroscopy on this group of patients, there is a debate in the literature on whether the arthroscopy should be conducted. thus, the purpose of this study is to examine the mbp with and without ankle arthroscopy.

Eligibility criteria:
inclusion criteria: 1. able to independently consent for surgery 2. able to demonstrate an understanding of study procedures 3. adult patient 18 years of age or older 4. all active duty soldiers, veterans, dependents 5. ability to comply with study procedures for the entire length of the study 6. presence of lateral ankle instability meeting operative criteria listed in 6.2.1 with documented failed conservative measures such as: physical therapy, ankle braces, and rest exclusion criteria: 1. unable to obtain medical clearance for surgery 2. recent (1 month) febrile illness that precludes or delays participation 3. history of or suspected of drug/alcohol abuse, as these patients may not be compliant with physical therapy. all patients are required to be immobilized for 6 weeks after surgery 4. pregnant women, this is an elective procedure and a mbp or ankle arthroscopy is not typically offered to pregnant women. screening for pregnancy is done as part of standard of care
epidural low dose morphine in postoperative pain after posterior lumbar spinal surgery

Conditions: Morphine

Summary: the effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study


Eligibility criteria:
inclusion criteria: * age \> 18 yrs * good orientation and communication exclusion criteria: * opioids or sulfonamides allergy * contraindication for use * epidural morphine * selective cox 2 inhibitor * patient-controlled analgesia (pca) * asa class \> 3 * bmi ≥ 35 kg/sq.m. * preoperative use of opioids within 6 wks * intraoperative bleeding \> 1000ml
safety and effectiveness of an hydrophilic acrylic intraocular lens

Conditions: Cataract Senile

Summary: evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens

to show safety and the effectiveness in regard to the monocular corrected distance visual acuity (cdva) at 12-24 month postoperative.

Eligibility criteria:
inclusion criteria: * patients of any gender, aged 18 years or older at the time of the surgery * patients who had an uncomplicated (no intra-operative complication) aged-related cataract surgery * currently implanted with the study device into the capsular bag in at least one eye * one-year post surgery follow-up (365 days -14 days/+365 days) for the study eye at the time of the postoperative visit * patient is willing and capable of providing informed consent * patient is willing and capable of complying with visits and procedures as defined by this protocol exclusion criteria: * preoperative corrected distance visual acuity (cdva) better than 0.3 logmar (0.5 decimal) or cdva not available preoperatively * preoperative documented endothelial cell count of less than 2000/mm2 (if available) * any preoperative documented ocular disorder that could potentially cause a clinically significant future visual acuity loss * any preoperative documented clinically significant anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) * any preoperative documented clinically significant abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies) * any preoperative documented clinically significant condition that could affect iol stability (e.g. zonular dialysis, evident zonular weakness or dehiscence, etc.) * any preoperative documented history of clinically significant retinal pathologies or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerve atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) that could alter or limit final postoperative visual prognosis * any preoperative acute infection (acute ocular disease, external/internal infection, systemic infection) * any previous preoperative intraocular and corneal surgery * preoperative documented uncontrolled glaucoma or iop higher than 24mmhg under ocular hypertension treatment * preoperative documented or current systemic or ocular pharmacotherapy that effects patients' vision * any other preoperative documented or current pathology or condition that could be a risk for the patient according to the investigator opinion * women during pregnancy and/or lactation at time of enrollment into the study * patients unable to meet the limitations of the protocol or likely of non-cooperation during the trial * patients whose freedom is impaired by administrative or legal order * subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, that do not affect patients' vision
a study of palifermin for the reduction of oral mucositis in subjects with advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rhukgf) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.

this study is being conducted to evaluate the efficacy of palifermin administered intravenously (iv) in weekly doses (minimum of 7 weekly doses, until rt was complete) in reducing the incidence of severe (world health organization \[who\] grade 3 or 4) oral mucositis in subjects with locally advanced hnc receiving rt concurrent with ct (rt/ct) as adjuvant treatment for their disease (postoperative setting). this study will assess the safety and tolerability of palifermin at the dose of 120 μg/kg iv administered weekly (minimum 7 weekly doses, until rt was complete) in this subject population. this study will also evaluate the effect of palifermin on the clinical sequelae of severe om (eg, average subject-reported mouth and throat soreness \[mts\] score), and on rt-induced xerostomia in this population, as well as the long-term effects of palifermin on disease outcome and survival in this population.

Eligibility criteria:
inclusion criteria: * history of histologically documented squamous cell carcinoma ( ajcc \[american joint committee on cancer\] stage ii, iii, iva or ivb) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (r0, r1) and candidates for adjuvant rt/ct * radiation treatment field to receive planned dose of at least 50gy to area of the oral cavity/oropharynx mucosa that can be visualized * eastern cooperative oncology group (ecog) performance status less than or equal to 2 * functional hematopoietic and hepato-renal systems exclusion criteria: * tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors * metastatic disease (m1) stage iv c * presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer or basal cell carcinoma of the skin) * history of chronic pancreatitis or episode of acute pancreatitis within the last year * prior radiation to the site of the disease, or prior chemotherapy-

Keywords: oncology kgf palifermin oral mucositis clinical trial amgen head and neck
the belgian real (be.real) registry

Conditions: Atherosclerotic Cardiovascular Disease

Summary: this is an observational non-interventional study. the visit schedule is according to the routine clinical practice. only data corresponding to study variables within the specified study period will be collected. the study will recruit patients into one single cohort: inclisiran in combination with other llts. the patients will receive inclisiran therapy as per the approved label and belgian reimbursement conditions.

the study aims to assess the effectiveness, safety and adherence for inclisiran in combination with lipid-lowering therapy (llt) under conditions of routine clinical practice. the inclisiran cohort will include patients receiving inclisiran therapy as per the approved label independently of background standard of care (soc) therapy. this study will include both primary data collection and secondary use of data. * prospective data collection: patients will be enrolled over a period of 6 months between 01-december-2022 and 31-may-2023 and will have a maximum follow-up of 39 months or 8 injection visits. * retrospective data collection: retrospective data will also be captured for patients with a first prescription between 01-may-2022 and study start and will be followed up for a maximum of 39 months to assess for study outcomes. in this case, baseline data and data of the first injection visits will be retrieved by the physician and captured in the clinical report form (crf), followed by prospective data collection during the rest of the follow-up period.

Eligibility criteria:
inclusion criteria: 1. patients who are 18 years or older. 2. patients with atherosclerotic cardiovascular disease (ascvd) who are eligible for commercially available leqvio, as defined by the reimbursement criteria: patients with ascvd documented by previous coronary heart disease (chd), cerebrovascular disease or peripheral artery disease (pad) and ldl-c ≥ 100mg/dl despite a treatment of min 6 weeks with max tolerated statin (unless intolerance or contra-indication) in combination with ezetimibe (unless intolerance or contra-indication). 3. heterozygous familial hypercholesterolemia (hefh) patients with documented ascvd who are eligible for commercially available leqvio. 4. patients who provide written informed consent to participate in the study. exclusion criteria: 1. patients who have received inclisiran previously. 2. patients participating in a clinical trial with investigational product. 3. heterozygous familial hypercholesterolemia patients without established atherosclerotic cardiovascular disease.

Keywords: nis atherosclerotic cardiovascular disease ascvd be.real be real inclisiran belgium
pre-discharge vs. early post-discharge stress testing and grace score for safe discharge of acs-patients with a negative hs-troponin t result

Conditions: Major Adverse Cardiovascular Events; Troponin T; GRACE Score

Summary: new high-sensitivity cardiac troponin (hs-ctn) assays allow earlier detection of acute myocardial infarction (ami). furthermore, elevated values were associated with an increased risk of recurrent ami or death. therefore, guidelines recommend an early invasive strategy in patients with elevated admission values and kinetic changes. other criteria for an early invasive strategy include a grace risk score \>140 points or other cardiovascular risk factors. hs-ctn assays allow discrimination of patients at very low and high risk. studies confirmed safety of early discharge protocols in patients with unstable angina (uap). the aim of this study is to 1) confirm the safety of early discharge without invasive strategy in patients with uap and to 2) review the optimal timing of stress-testing. therefore, patients are being randomized into 2 groups with pre-discharge and early post-discharge stress-testing. endpoints are major adverse cardiovascular events within 30 and 90 days.


Eligibility criteria:
inclusion criteria: * patients presenting to the emergency department ("chest pain unit") * typical angina pectoris * absence of symptoms since presentation * at least 18 years * low grace risk score (\<140 points) * informed consent, signed agreement exclusion criteria: * conditions with need for immediate workup * mental disorders * dementia * pregnancy, breast feeding

Keywords: stress testing troponin t grace score outcome
systane® hydration pf and systane® hydration preserved

Conditions: Dry Eye

Summary: the purpose of this post-market clinical follow-up (pmcf) study is to assess the performance and safety of systane hydration preservative free (pf) in subjects experiencing dry eye symptoms (group 1) and in contact lens (cl) wearers experiencing discomfort due to cl-related dryness (group 2) and also systane hydration preserved in cl wearers experiencing discomfort due to cl-related dryness (group 3). statistical analyses will be presented by group.

subjects will participate in the study for approximately 30 days, with a phone call scheduled on day 15 ± 2 (visit 2) and a follow-up visit scheduled on day 30 ± 2 (visit 3). subjects will be asked to complete patient questionnaires on day 1 and at visit 3 (impact of dry eye on everyday life - symptom bother \[ideel-sb\] or contact lens dry eye questionnaire \[cldeq-8\] and comfortable wear time questions).

Eligibility criteria:
inclusion criteria: * subject must be able to understand and sign an informed consent form * subject with mild to moderate dry eye * subject with cl-related dry eye symptoms * other protocol-defined inclusion criteria may apply exclusion criteria: * has suffered any ocular injury to either eye in the past 3 months prior to screening. * has undergone any other ocular surgery (including intraocular surgery) within the past 6 months or has any ocular surgery planned during the study. * other protocol-defined exclusion criteria may apply
anorexia nervosa and its effects on brain function, body metabolism and their interaction

Conditions: Anorexia Nervosa

Summary: the neuromolecular and metabolic underpinnings of anorexia nervosa (an) are studied using multi-modal molecular (positron emission tomography with two different radioligands) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. subjects with an and normal weight adolescents will be studied with pet and mri and followed for five years.

a total of sixty females (30 with an, 30 healthy controls) are recruited into this prospective study. the subjects will undergo physical examination, body tissue composition measurement, functional and structural mri of the brain and body, and positron emission tomography (pet) with ligands \[18f\]-fdg, and \[11c\]carfentanil. subjects' weight and physical condition will be followed up for 5 years. the study will start in august 2020 and end in the fall of 2028.

Eligibility criteria:
inclusion criteria for an: 1. female sex 2. age 18-32 3 years 3. bmi \< 17.5 kg/m2 4. currently fulfilling modified dsm-iv diagnosis of an with or without amenorrhea, onset age before 25 years 5. diagnosed less than 2 years ago for controls: 1. female sex 2. age 18-32 3 years 3. bmi 19 20-25 kg/m2 4. no lifetime history of obesity (bmi ≥\> 30) or eating disorders exclusion criteria: 1. any chronic disease or medication that could affect glucose metabolism or neurotransmission 2. history of psychiatric disorders (excl. an for the corresponding study group) 3. smoking of tobacco, taking of snuffs, or use of narcotics 4. abusive use of alcohol

Keywords: anorexia nervosa metabolism functional imaging pet