Kornimate/medical-research-clean huggingface dataset:
investigation of the clinical safety and efficacy of long-term treatment with fycompa tablets in adult epilepsy patients with partial-onset seizures (with or without secondary generalized seizures) or primary generalized tonic-clonic seizures

Conditions: Partial Seizures (With or Without Secondary Generalized Seizures); Primary Generalized Tonic-clonic Seizures

Summary: the objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized tonic-clonic seizures who receive long-term treatment with fycompa: 1. unknown adverse drug reactions (adrs); 2. occurrence of adrs; 3. factors that are likely to affect safety and efficacy; 4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items; 5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).


Eligibility criteria:
inclusion criteria: * epilepsy participants at least 18 years of age with: * partial seizures (with or without secondary generalized seizures) * primary generalized tonic-clonic seizures exclusion criteria: * participants previously treated with fycompa

Keywords: adult epilepsy participants partial seizures primary generalized tonic-clonic seizures
e7389 in treating patients with recurrent or progressive stage iiib or stage iv non-small cell lung cancer

Conditions: Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Summary: this phase ii trial is studying how well e7389 works in treating patients with recurrent or progressive stage iiib or stage iv non-small cell lung cancer. drugs used in chemotherapy, such as e7389, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

objectives: i. evaluate the antitumor activity of e7389 (eribulin mesylate), in terms of objective response rate, in patients with recurrent or progressive stage iiib or iv non-small cell lung cancer. ii. evaluate the time to progression and overall survival of patients treated with this drug. iii. evaluate the toxicity profile of this drug in these patients. outline: this is a multicenter study. patients receive eribulin mesylate iv over 1-2 minutes on days 1 and 8. treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed once monthly for at least 6 months and then periodically thereafter.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer (nsclc) * stage iiib or iv disease * recurrent or progressive disease * measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral ct scan * must have received prior treatment with platinum-based therapy and a taxane * asymptomatic brain metastasis allowed provided off steroids for \> 2 weeks * zubrod performance status (ps) ≤ 2 or karnofsky ps 60-100% * life expectancy \> 3 months * platelet count ≥ 100,000/mm³ * bilirubin ≤ 2.0 mg/dl * ast/alt ≤ 2.5 times upper limit of normal * creatinine normal or creatinine clearance ≥ 50 ml/min * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no neuropathy ≥ grade 2 * no uncontrolled illness including, but not limited to, any of the following: * ongoing or active infection * symptomatic congestive heart failure * unstable angina pectoris * cardiac arrhythmia * psychiatric illness or social situations that would preclude study compliance * no other concurrent investigational agents * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin c) and recovered * at least 2 weeks since prior radiotherapy, including palliative radiotherapy, and recovered * no more than 2 prior chemotherapy regimens for nsclc in the metastatic or adjuvant setting * no concurrent combination antiretroviral therapy for hiv-positive patients exclusion criteria: * absolute neutrophil count ≥ 1,500/mm³ * no history of allergic reactions attributed to compounds of similar chemical or biological composition to e7389
effectiveness of electrotherapy treatment in chronic low back pain

Conditions: Chronic Low Back Pain

Summary: this study investigates the effectiveness of a specific electrotherapy treatment for individuals with chronic non-specific low back pain. the participants, who had low back pain for more than three months, were divided into two groups: a treatment group and a waitlist control group. the treatment group received electrotherapy using the stimawell 120mtrs system, which provided electrical stimulation and heat therapy to the entire spine over four weeks. the study assessed various outcomes, including pain levels, disability, and quality of life, before and after the intervention.


Eligibility criteria:
inclusion criteria: * 18-65 years old, * lbp for more than three months, * pain of 3 or more according to the numeric pain scale * being literate exclusion criteria: * having a pacemaker, * body mass index greater than 30, * pathologies of the cervical or lumbar region, * cervical radiculopathy, thoracic outlet syndrome, malignant conditions, * systemic diseases, such as neurological, psychological, cardiovascular or rheumatologic conditions, loss of function due to these diseases, * history of surgery on the spine or upper extremities, * acute infection

Keywords: chronic low back pain electrotherapy
macular thickness measurements using retinal-thickness oct

Conditions: Age-Related Macular Degeneration; Diabetic Retinopathy

Summary: comparison between retinal measurements, done by the rt (retinal thickness) imaging and a commercial oct (optical coherence tomography)


Eligibility criteria:
inclusion criteria: 1. ability and agreement to give informed consent (ic) 2. diagnosis of amd or dr in se by oct 3. ability to undergo oct scans exclusion criteria: 1. amd and dr in the same se 2. evidence of macular disease other than amd or dme in se
early mobilization in cardiovascular units

Conditions: Cardiovascular Diseases

Summary: insufficient mobility contributes to functional decline in hospitalized cardiac patients. early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay \[1\]. therefore, there is a need to adapt and implement early mobilization programs in quebec hospitals. the overall goal of this study is to adapt and implement an early mobilization program in the cardiovascular units of the jewish general hospital (jgh).

background: insufficient mobility contributes to functional decline in cardiovascular units. early mobilization programs were shown to improve functional status, increase the likelihood of home discharges, and reduce the length of stay \[1\]. one example is the level of function (lof) mobility scale implemented in the cardiovascular units at the jewish general hospital, an academic tertiary care centre in montreal, quebec \[2\]. despite evidence supporting the benefits of early mobilization programs, hospitalized individuals in cardiovascular units spend most of the day in bed \[1-6\]. therefore, there is a need to adapt and implement early mobilization programs in quebec hospitals. this project is research nested in a quality improvement initiative for the jewish general hospital cardiovascular units. objectives: 1) adapt an early mobilization program in a hospital setting; 2) develop strategies to overcome individual and organizational barriers to implementing an early mobilization program; 3) assess the reach, acceptability, and fidelity of implementing an early mobilization program; and 4) assess the program's impact on patients and the organization. methods: a 3-phase study using an iterative participative approach. phase 1: a qualitative design to adapt an early mobilization program. phase 2: mixed methods repeated measures design to assess barriers and facilitators to implementing the program and develop implementation strategies. phase 3: an interrupted time series design to assess the implementation and the impact of the program. expected contribution: early mobilization programs in the cardiovascular units can improve the quality of care provided to these patients and promote further clinician-researcher partnerships, contributing to improved uptake of best practices in this clinical context.

Eligibility criteria:
inclusion criteria: * all healthcare professionals working in the cardiovascular unit at the jewish general hospital. * all patients admitted to the cardiovascular unit at the jewish general hospital. exclusion criteria: * patients who don't speak english or french.

Keywords: early mobilization program cardiovascular level of mobility
bioequivalency study of valacyclovir hydrochloride 1000 mg under fasting conditions

Conditions: Herpes Zoster; Shingles; Genital Herpes

Summary: the objective of this study was to prove the bioequivalence of valacyclovir hydrochlorothiazide caplet under fasting conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product.
improving perception of speech in noise in children with communication disorders

Conditions: Speech Perception

Summary: smarty ears has developed a prototype of an innovative therapeutic training system to improve speech perception in noise by training children on interrupted noise (which has silent intervals that allow for fragments of the target to be heard). the study will attempt to validate the technology and gather initial design feedback from clinicians and caregivers and from children with asd and hl.

recent evidence indicates that listening in interrupted noise can provide perceptual benefits, such as remapping the auditory environment and learning to use acoustic cues. the developed technology, uses adaptive listening training that automatically increases noise level difficulty as performance improves, and includes age appropriate rewards to maintain interest. the mobile app includes an initial and final screening, a training system that administers training via the child's own mobile device, and detailed performance dashboard. the study will attempt to validate the technology by gathering feedback from clinicians and caregivers and from children with asd and hl.

Eligibility criteria:
inclusion criteria: * for all children: normal or corrected to normal vision. * for children with typical development normal or corrected to normal vision + normal hearing. * for children with hl children must have at least one year experience with amplification (i.e hearing aids) and no threshold\> 70 db. exclusion criteria: * to participate, all children must be able to comply with directions and engage in tasks that require some expressive language response on the language and cognitive measures (i.e. children who are considered to be in the "word combinations" or "sentences expressive language" phase; tager-flusberg et al., 2009).

Keywords: asd speech in noise hearing loss speech-to-noise ratio
functional and morphologic aspects of intravitreal triamcinolone for uveitis-associated cystoid macular edema

Conditions: Uveitis Related Cystoid Macular Edema

Summary: purpose: to evaluate the effect of intravitreal triamcinolone acetonide (ivta) on uveitis-associated cystoid macular edema (cme) using high resolution optical coherence tomography (sdoct) in conjunction with thorough visual function testing. methods: 28 patients with uveitis-associated cme were examined before intravitreal triamcinolone injection (ivta) (v1) and at day 1 (v2), week 1 (v3) and month 1 (v4) after injection. retinal anatomy was evaluated using cirrus hd-oct (carl zeiss meditec). visual function testing consisted of assessing etdrs distance visual acuity (va), reading acuity and reading speed using a standardized german-language test (radner reading charts), contrast sensitivity using pelli-robson contrast sensitivity charts and fundus-controlled microperimetry using the mp-1 microperimeter (nidek). here we utilized a cartesian grid consisting of a central locus and three concentric box-shaped stimulation areas. the changes of retinal anatomy over time were compared to the respective outcome of visual function.


Eligibility criteria:
inclusion criteria: * intraocular inflammation * able to read * \> 18 years old exclusion criteria: * cataract * amblyopia * dyslexia * already applicated intravitreal triamcinolone for current cystoid macular edema

Keywords: uveitis cystoid macular edema microperimetry functional visual acuity intravitreal triamcinolone
bandage contact lenses versus eye patching of müller's muscle-conjunctival resection

Conditions: Eyelid Diseases

Summary: patients with blepharoptosis who are treated with müller's muscle-conjunctival resection (mmcr) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. this study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (vas) and objectively evaluate the cornea with a tear break-up time (tbut) test and fluorescein staining following mmcr that was managed by either a bandage contact lens (bcl) or eye patching.

patients with blepharoptosis who are treated with müller's muscle-conjunctival resection (mmcr) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. this study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (vas) and objectively evaluate the cornea with a tear break-up time (tbut) test and fluorescein staining following mmcr that was managed by either a bandage contact lens (bcl) or eye patching.

Eligibility criteria:
inclusion criteria: * patients who had unilateral ptosis and underwent unilateral mmcr exclusion criteria: * patients were excluded if they had previous eyelid surgery or had another known eye disease, such as ocular surface disorders, dry eye syndrome.

Keywords: patient comfort
circadian rhythm impact on tnbc response to neoadjuvant immunotherapy

Conditions: Triple Negative Breast Cancer (TNBC)

Summary: circadian is a prospective randomized clinical trial designed to evaluate the impact of pembrolizumab infusions' time-of-day on pathological complete response (pcr) rate among tnbc patients undergoing neoadjuvant treatment.

patients will be randomized 1:1 to receive all neoadjuvant pembrolizumab cycles (400 mg every 6 weeks) before versus after noon. subjects will be stratified based on clinical stage at diagnosis (st. ii vs iii). primary outcome will be pcr rate. as a secondary outcome, we will assess for treatment related toxicity. for planned exploratory circadian rhythm evaluation, daily body temperature and salivary cortisol variation will be measured before each ici infusion and the munich chronotype questionnaire (mctq) will be applied. to assess for emotional stress, physical exercise habits, stimulating substances use and light exposure, patients will also be subjected to the distress thermometer and a lifestyle questionnaire. for planned exploratory biomarker research, tumor infiltrating lymphocytes (tils) analysis will be performed on the initial diagnostic biopsy and after surgery, on residual tumor (in patients not achieving pcr). cytokine quantification and bulk rna sequencing plus flow cytometry studies for immune populations profiling will be performed on peripheral blood, at baseline and before surgery, to check for potential biomarkers of circadian modulation.

Eligibility criteria:
inclusion criteria: * female sex * age 18 - 75 years old * diagnosed with stage ii or iii tnbc and candidates for neoadjuvant treatment with cht+pembrolizumab after multidisciplinary group discussion. exclusion criteria: * patients unable to understand or consent to the study; * patients not completing ≥2 cycles of planned neoadjuvant pembrolizumab cycles or ≥50% of planned neoadjuvant cht cycles; * patients under daily ≥10 mg of prednisolone or equivalent

Keywords: tnbc immunotherapy circadian rhythm
duowell® vs. telmisartan monotherapy in mild dyslipidemia patients with hypertension

Conditions: Hypertension; Dyslipidemia

Summary: this study is to evaluate effect and safety on central blood pressure with duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.


Eligibility criteria:
inclusion criteria (all of the followings) * 40 to 75 years old diagnosed with hypertension * at screening, sbp ≥ 140 mmhg * at randomization, 130 mmhg ≤ sbp ≤160 mmhg or 80 mmhg ≤ dbp ≤ 100 mmhg * at screening, ascvd risk ≥ 5 % * those who did not take the dyslipidemic medications during screening or who stopped medication for more than 2 months * at screening, 130 mg/dl ≤ calculated (or measured) serum ldl-c ≤ 190 mg/dl * pregnancy test negative and and who has agreed to perform effective contraception during the clinical trial exclusion criteria (any of the followings) * known hypersensitivity to at-1 receptor blockers or statins * those who are treated with secondary hypertension during screening * those who are being treated for malignant hypertension during screening * those who are taking concurrent medication that may affect blood pressure during screening * those who have been diagnosed with myocardial infarction or unstable angina or stroke within the last 6 months at screening * patients with heart failure nyha iii-iv or left ventricular ejection fraction \<40% within the last 6 months at screening * patients with valve disease with hemodynamically significant (over moderate degree) obstructive * those with known atrial fibrillation or atrioventricular conduction disturbance * those who show the following numerical values during the screening test 1. cpk ≥ 3 times the normal upper limit 2. serum creatinine \> 3 mg/dl 3. serum potassium \> 5.5 mmol/l 4. alt or ast ≥ 3 times the upper normal limit * those with known bilateral renal artery stenosis * patients who underwent open heart surgery within 4 weeks prior to randomization and who had a cardiac surgery plan * those taking statins within 8 weeks before randomization * those with severe obstructive, limited or other pulmonary disease history * those with non-cardiac disease that can significantly shorten the expected life span to less than 2 years (eg, severe cancer) * at screening, anti-hiv ab, hbsag, hcv ab positive
a trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted globally. the aim of this trial is to compare cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events.


Eligibility criteria:
inclusion criteria: - type 2 diabetes - age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors - hba1c (glycosylated haemoglobin) above or equal to 7.0% or hba1c below 7.0% and current insulin treatment corresponding to above or equal to 20 u of basal insulin per day - one or more oral or injectable antidiabetic agent(s) exclusion criteria: - an acute coronary or cerebrovascular event in the previous 60 days - planned coronary, carotid or peripheral artery revascularisation - chronic heart failure nyha (new york heart association) class iv - current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
study to compare safety and efficacy of hx575 epoetin alfa and us-licensed epoetin alfa

Conditions: Anemia; Chronic Kidney Disease (CKD)

Summary: the purpose of this study is to show biosimilarity of hx575 epoetin alfa with the us licensed reference product epogen®/procrit® when applied subcutaneously. this study is intended to generate data supporting that the efficacy and safety under treatment with hx575 and epogen®/procrit® are comparable.

this is a randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of hx575 epoetin alfa vs. us-licensed epoetin alfa (epogen®/procrit®) in the treatment of anemia associated with chronic kidney disease (ckd).

Eligibility criteria:
inclusion criteria: * patients with end stage renal disease (stage ckd 5d), receiving stable subcutaneous maintenance therapy with epogen® or procrit® at least once per week * mean hemoglobin level between 9.0 - 11.5 g/dl during the screening period * adequate iron substitution exclusion criteria: * contraindications for erythropoiesis stimulating agent (esa) therapy * history of pure red cell aplasia (prca), or anti-erythropoietin (epo) antibodies * known human immunodeficiency virus (hiv) or hepatitis b infection * hepatitis c infection on an active treatment * symptomatic congestive heart failure (new york heart association \[nyha\] class iii and iv) * unstable angina pectoris, or cardiac infarction during the last 6 months prior to randomization * percutaneous coronary intervention, or coronary artery bypass grafting during the last 6 months prior to randomization * history of malignancy of any organ system * systemic lupus erythematous * immunocompromized patients other in-/exclusion criteria may apply

Keywords: erythropoietin alfa ckd 5d