Kornimate/medical-research-clean huggingface dataset:
a study of methoxy polyethylene glycol-epoetin beta (mircera) for the treatment of chronic renal anemia in participants with diabetic nephropathy

Conditions: Anemia

Summary: this single arm, open label study will assess the efficacy, safety and tolerability of methoxy polyethylene glycol-epoetin beta for the treatment of chronic renal anemia in participants with chronic kidney disease (ckd) secondary to diabetes. participants who are not on dialysis and not currently treated with erythropoiesis stimulating agents (esas) will receive methoxy polyethylene glycol-epoetin beta subcutaneously every 4 weeks (q4w). the starting dose of 1.2 microgram/kilogram (mcg/kg) methoxy polyethylene glycol-epoetin beta will be adjusted according to hemoglobin levels. anticipated time on study treatment is 28 weeks.


Eligibility criteria:
inclusion criteria: * diabetic nephropathy * chronic renal anemia with stage iii-iv ckd * not on dialysis and not expected to require dialysis within the next 6 months * not receiving any esa in the 2 months prior to study * adequate iron status exclusion criteria: * transfusion of red blood cells during the previous 2 months * known or clinical suspicion of pure red cell aplasia * hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication * haemoglobinopathy * significant acute or chronic bleeding
narrow band green light and migraine

Conditions: Migraine; Headache

Summary: study volunteers are asked to use the allay lamp routinely during the 6-week study period. a web based survey is provided when the lamp is purchased for study volunteers to complete. a daily usage paper diary is sent with the lamp so that volunteers can keep track of the frequency and duration of lamp usage and any noticeable benefits. at the end of six weeks a second survey is sent to study volunteers to capture their perceptions of potential lamp benefits with respect to headache frequency and their experience of migraine specific symptoms.


Eligibility criteria:
inclusion criteria: * adults with headaches or migraines. exclusion criteria: * not having headaches or migraines
comparison between the efficacy of cimt and ndt along with conventional physiotherapy treatment on upper extremity rehabilitation among patients of stroke

Conditions: Strokes Thrombotic

Summary: to compare the efficacy of cimt and ndt among stroke patients to study the phenomena of transfer of training to study relationship between the mmse score and stroke rehabilitation

this research aims to provide a comprehensive comparison of cimt and ndt, supplemented by conventional physiotherapy, in the rehabilitation of upper extremity function among stroke patients. the findings will inform clinical practice, guiding the development of optimized, patient-centered rehabilitation strategies.

Eligibility criteria:
inclusion criteria: * participants will be aged 40-65 years and will have experienced either a hemorrhagic or ischemic stroke with hemiplegic presentation within the past 1 to 6 months. additionally, they must have a mini-mental state examination (mmse) score of 23. exclusion criteria: * participants with visual or auditory deficits, musculoskeletal (msk) disorders, mental impairments, or a history of surgery will be excluded from the study.

Keywords: (cimt) (ndt)
radiological evaluation of the penis before and after a botox injection

Conditions: Erectile Dysfunction

Summary: the goal of this clinical trial is to find out if injecting botox into men with erectile dysfunction makes their penis less stiff and gives them better erections. this will be done using a new ultrasound method. the main questions it tries to answer are: is botox injection safe and effective for men suffering from erectile dysfunction who failed other treatment methods? does this new method have any radiological criteria for penile tissues? • if botox is injected into the penis, is there a cut-off number for this technique that shows how much better things are before and after? before and after treatment, participants will rate how much their erections have improved, and investigators will connect their answers to the findings


Eligibility criteria:
inclusion criteria: * men with ed not responding to oral pde5is. exclusion criteria: * patients with penile prostheses. * patients diagnosed with peyronie's disease. * non-vascular erectile dysfunction. * medical comorbidities that would limit the benefit of ici such as uncontrolled diabetes mellitus, significant cardiovascular disease interfering with sexual activity, unstable psychiatric conditions, and the presence of anatomical, hormonal, or neurological abnormalities that would significantly impair erectile function. * patients with a history of radical pelvic surgery. * pelvic or spinal trauma
leadless electrocardiogram (ecg) evaluation study

Conditions: Heart Failure

Summary: the leadless electrocardiogram (lecg) is a new technology incorporated into the consulta crt-p to obtain an ecg signal from the consulta crt-p similar to a surface ecg obtained from the device programmer (pecg) or an external ecg machine. the purpose of the study is to obtain more data on leadless ecg to determine whether lecg during standard crt follow-up can indeed adequately replace surface ecg and to evaluate if it can be used during remote follow-up evaluations.

the leadless electrocardiogram (lecg) is a new technology incorporated into the consulta crt-p to obtain an ecg signal from the consulta crt-p similar to a surface ecg obtained from the device programmer (pecg) or an external ecg machine. the lecg signals are measured from three electrodes mounted on the outside of the pacemaker housing and provides an electrical far field signal of the electrical activity of the heart. the lecg provides three ecg channels as different projections of the electrical activity of the heart, similar to the surface ecg. clinical interest of lecg is threefold. first, ecg recordings are routinely used to perform pacemaker and cardiac resynchronization systems in-office follow-up mainly to determine pacing thresholds. connection of ecg electrodes to the patient as well as the time needed to acquire an acceptable ecg signal during routine follow-up could be saved using lecg which would make follow-up easier and less time consuming. secondly, connecting ecg electrodes requires the patient to be present at the clinic for the follow-up. use of lecg in conjunction with a transmitting system will allow remote patient follow-up. in that case, correct ventricular capture confirmation by the lecg is of key importance. finally, lecg stored in device memory at the time of an arrhythmia episode occurrence, can help better classify it. the following factors might influence the quality of the lecg and/or the axis of the lecg: * temporal changes of the electrode tissue interface due to device pocket healing process * changes in device position and orientation over time * body motion * poor lecg contact due to oversized device pocket with replacement procedure. the purpose of this study is to obtain more data on leadless ecg (lecg) to determine whether lecg during standard crt follow-up can indeed adequately replace surface ecg and to evaluate if it can be used during remote follow-up evaluations.

Eligibility criteria:
inclusion criteria: * patient with a crt-p indication and * patient who has signed an informed consent form. exclusion criteria: * patient younger than 18 years and/or * unable to complete the 1-month follow-up visit and/or * legally incompetent or illiterate and therefore unable to provide an informed consent

Keywords: heart failure cardiac resynchronization leadless ecg follow-up
cov-icu score, intensive care unit, sars-cov-2

Conditions: Coronavirus as the Cause of Diseases Classified Elsewhere

Summary: in the course of covid disease, some patients need intensive care treatment. we aim to find an answer to the question of whether the patient's crp, ferritin, d-dimer, oxygen saturation, lymphocyte count, and body mass index can be used as a criterion for admitting patients with covid to the intensive see unit.

it is aimed to determine the patients who are above the threshold value to be determined according to this scoring result. identifying patients who may need intensive care and following them closely will positively affect patient prognosis.

Eligibility criteria:
inclusion criteria: patients admitted to the intensive care unit with the diagnosis of covid exclusion criteria: \<18 years patients

Keywords: sars-cov-2, intensive care
fetal growth restriction & maternal cardiovascular risk

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to determine whether or not women with a history of having a baby with intrauterine growth retardation (iugr) was more likely to have risk factors for cardiovascular disease versus women with a pregnancy not complicated by iugr.

background: intrauterine growth restriction leads to major neonatal morbidity and mortality. moreover, recent birth registry studies have suggested that women bearing iugr babies may have an elevated risk of cardiovascular disease. design narrative: this cohort study tested whether exposed women, with a previous intrauterine growth restriction (iugr) baby, versus unexposed women, with a pregnancy not complicated by iugr, had elevations in markers of cardiovascular risk. exposure was defined among a geographically defined cohort as having had a singleton baby in the \ 20%tile. four to twelve years postpartum, women were assessed for multiple markers of cardiovascular risk, including blood pressure, lipids, adiposity, glucose and insulin, homocysteine and folate, markers of inflammation, markers of endothelial function, markers of angiogenesis, and markers of vascular function. data analysis consisted of anova and ancova analyses comparing the outcomes of cardiovascular markers among exposed and unexposed women.

Eligibility criteria:
inclusion criteria: * women 4 to 12 years after delivery of singleton infant * women who gave birth between 1997 and 2002 at magee-womens hospital in pittsburgh, pennsylvania exclusion criteria: * women who had preeclampsia * women who had prepregnancy hypertension * women who had diabetes * women who were currently pregnant or reported a prepregnancy chronic condition
counseling conditions for buprenorphine in a primary care clinic - 1

Conditions: Heroin Dependence; Opioid-Related Disorders; Substance Abuse, Intravenous

Summary: the purpose of this study is to compare the standard medical management (smm) vs. smm enhanced with additional education about addiction and recovery (enhanced medical management, emm)

a randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with standard or enhanced medical management. smm is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. emm is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report.

Eligibility criteria:
inclusion criteria: subjects meeting fda criteria for opioid agonist maintenance treatment and dsm-iv criteria for opioid dependence will be eligible for the study. women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy monitoring throughout the study. exclusion criteria include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand english; life-threatening or unstable medical problems.

Keywords: opioid-related disorders
phase ii study of salvage radiation treatment after b-cell maturation antigen chimeric antigen receptor t-cell therapy for relapsed refractory multiple myeloma

Conditions: Multiple Myeloma; Plasma Cell Neoplasm; Malignant Plasma Cell Neoplasm

Summary: this study is a phase ii study to determine the preliminary safety and efficacy of salvage radiation treatment after bcma car-t therapy in subjects with rrmm. the study population will consist of subjects with rrmm previously treated with soc bcma car-t cell therapy with active disease on the d30+ pet or other imaging scan after car-t infusion. patients who are planned for salvage chemotherapy less than 14 days after completion of radiation treatment will be excluded. radiation treatment will be to bony or soft tissue plasmacytomas in up to five radiation treatment fields to 10-20gy (or equivalent dose in 2gy fractions of 10-21gy). final dose, target, and technique are per treating radiation physician discretion within these guidelines. thirty patients will be enrolled. the co-primary endpoints are objective response rate (orr) at 6 months and duration of response (dor) among responders.

objectives primary objective: • the primary objective of the study is to evaluate the preliminary efficacy of salvage radiation therapy after bcma car-t cell therapy in subjects with rrmm. secondary objectives: • evaluate the safety of and other efficacy parameters of radiation treatment after bcma car-t cell therapy in subjects with rrmm exploratory objectives: * evaluate the immunophenotype and/or expression profile, and perform functional bulk and single cell analysis of car t cells, endogenous t cells as well as other immune cells in the blood, bone marrow and/or tumor tissue with bcma car-t therapy and rt * evaluate changes in the levels of cytokines, chemokines, and soluble factors in the blood with bcma car-t therapy and rt * evaluate changes in t cell receptor repertoire with bcma car-t therapy and rt * evaluate gut microbiome of patients treated with bcma car-t therapy and rt

Eligibility criteria:
inclusion criteria: subjects must satisfy the following criteria to be enrolled in the study: 1. subject is ≥ 18 years of age at the time of signing the informed consent form (icf) 2. subject is diagnosed with multiple myeloma 3. subject previously received treatment with standard of care bcma car-t cell therapy 4. day 30 or later pet scan or other imaging scan after car-t infusion shows active disease 5. subject has at least one myeloma lesion (plasmacytoma either in bone or soft tissue) that can be treated with radiation 6. able to provide informed consent exclusion criteria: the presence of any of the following will exclude a subject from enrollment: 1. subjects in whom salvage chemotherapy is planned less than 14 days after the completion of radiation treatment 2. subject is undergoing active treatment for another malignancy other than multiple myeloma 3. pregnant women will be excluded from this study.
cognitive-behavioral therapy for adults with attention-deficit/hyperactivity disorder inattentive presentation

Conditions: ADHD Predominantly Inattentive Type

Summary: using a randomized controlled design, standard treatment of group cognitive-behavioral therapy (cbt) according to the hesslinger protocol is compared to a newly developed group treatment specifically designed for adult patients with adhd inattentive presentation (adhd-i) called cbt for adhd-i (caddi). research setting is psychiatric outpatient clinics. research hypotheses include: 1. the caddi protocol is more effective than standard treatment in terms of behavioral activation, procrastination, depressive symptoms, functional impairment, and quality of life, 2. is equally effective in terms of adhd symptoms, 3. is more appreciated and tolerable, and 4. outcome is mediated by mindful awareness. effects are followed up at 6 and 12 months post treatment.


Eligibility criteria:
inclusion criteria: 1. principal diagnosis of adhd inattentive presentation 2. 18 years of age or older 3. if on medication, it needs to be well-established since three months, and 4. prior psycho-educational intervention exclusion criteria: 1. intellectual impairment 2. substance use disorder 3. difficulties in adherence to medical or other treatment 4. social and/or psychiatric problems to such an extent that they prevent focusing on treatment, or 5. simultaneous psychological treatment
risk stratification of covid-19 patients discharged from the emergency department

Conditions: Covid19

Summary: risk stratification of covid-19 patients is essential to define their appropriate treatment setting. so far, available studies have focused on morbidity and mortality prediction in patients admitted to hospital. in the emergency department (ed), decision on home discharge versus hospital admission for covid-19 is cumbersome. while facing a dramatic second wave of sars-cov-2, shortage of hospital beds has further increased the challenge. the present study will prospectively evaluate the clinical outcomes of patients discharged from the ed. stratification will be based on a composite of demographic, clinical and lung imaging variables. results will be used to develop standardized decision rules for safe home discharge of patients with covid-19 evaluated in the ed.

patients with inclusion criteria and without exclusion criteria, evaluated in the participating eds, will be enrolled in the study. patients will undergo standard medical evaluation by the attending physician(s), following local guidelines and best medical practice, independent of participation to the study. the following data will be recorded, when available: * demographic/clinical: age, gender, symptoms (type, time from onset), comorbidities, glasgow coma scale score, respiratory rate, peripheral oxygen saturation * biochemical: urea, creatinine, c-reactive protein, procalcitonin, lactate dehydrogenase, white blood cell count, lymphocyte count, d-dimer * lung ultrasonography: site/type of b lines, consolidations, pleural effusion * radiology: chest x-ray result, chest ct result upon discharge, patients will be encouraged to contact emergency medical services or return the ed if needed, in case of clinical worsening. the following endpoint will be assessed at 30 days after ed discharge, through standardized telephone interview and healthcare/other database query: any further hospital admission (for covid-19 or other disease), death (for covid-19 or other disease), respiratory failure/ventilation/intensive care admission (only for hospitalized covid-19 patients). data analysis will focus on the outcome incidence in the study cohort, stratified by a composite of demographic/clinical, biochemical and imaging variables. a key stratification tool will be the 4c mortality score (bmj 2020; 370 doi: https://doi.org/10.1136/bmj.m3339). additional integration of study variables will be evaluated to improve stratification and prediction.

Eligibility criteria:
inclusion criteria: * symptomatic covid-19 confirmed by treating physician * positive nasopharyngeal swab for sars-cov-2 (performed during the ed visit or within last 14 days) * first ed visit for suspected or confirmed covid-19 (within last 30 days) * home discharge from ed based on treating physician's or patient's decision exclusion criteria: * age \<18 years * nursing home resident * already on home oxygen therapy * previous ed visit for suspected or confirmed covid-19 (within last 30 days) * informed consent denial * follow-up not feasible

Keywords: emergency department admission discharge risk
switching from a tenofovir disoproxil fumarate (tdf) containing regimen to elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (e/c/f/taf) fixed-dose combination (fdc) in virologically-suppressed, hiv-1 infected adults aged ≥ 60 years

Conditions: HIV-1 Infection

Summary: the primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (e/c/f/taf) relative to unchanged current antiretroviral therapy (art) by assessing spine and hip bone mineral density (bmd) measured at week 48 in virologically-suppressed, hiv-1 infected participants aged ≥ 60 years.


Eligibility criteria:
key inclusion criteria: * currently receiving a tdf and ftc or 3tc-containing 'backbone' (maximum 2 nrtis) regimen plus a third agent for ≥ 6 consecutive months prior to screening visit. for individuals with 3 or more art regimens, a regimen history must be provided for approval by the sponsor. refer to assigned interventions for allowed third agents of the current regimen. * documented plasma hiv-1 rna levels \ 50 and \< 400 copies/ml) is acceptable, only if hiv-1 rna is \< 50 copies/ml immediately before and after the "blip". * plasma hiv-1 rna level \< 50 copies/ml at screening visit * adequate renal function * estimated glomerular filtration rate ≥ 30 ml/min according to the cockcroft-gault formula (egfrcg) and are on arvs that are appropriately dose adjusted for renal function per package insert * all documented historical plasma genotype(s) must not show resistance to tdf or ftc, including, but not limited to the presence of reverse transcriptase resistance mutations k65r, k70e, m184v/i, or thymidine analog-associated mutations (tams) that include m41l, l210w, d67n, k70r, t215y/f, k219q/e/n/r. if historical plasma prior to first art is not available or individual has 3 or more art regimens, individuals will have proviral genotype analysis prior to day 1 to confirm absence of archived resistance to tdf or ftc. * study performed dual energy x-ray absorptiometry (dxa) scan and t-score received prior to day 1 key exclusion criteria: * previous use of any approved or experimental integrase strand transfer inhibitor (insti) (for any length of time) if the current regimen contains a pi/r * individuals will have no evidence of previous virologic failure on a pi/r or insti-based regimen (with or without resistance to either class of arv) * a new aids-defining condition diagnosed within the 30 days prior to screening (except cd4+ cell count and/or percentage criteria) * hepatitis c virus that would require therapy during the study * individuals receiving ongoing treatment for bone disease (eg, osteoporosis), including bisphosphonates, denosumab, and strontium ranelate note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: hiv 1 infection hiv virologically-suppressed