Kornimate/medical-research-clean huggingface dataset:
study of isb 1342, a cd38/cd3 bispecific antibody, in subjects with previously treated multiple myeloma

Conditions: Relapsed/Refractory Multiple Myeloma

Summary: the purpose of this study is to assess safety, efficacy, pharmacokinetic (pk)/pharmacodynamic (pd), and immunogenicity with isb 1342 in subjects with relapsed/refractory multiple myeloma.

this study is an open-label, multi-center, phase 1 study of isb 1342 in subjects with relapsed/refractory multiple myeloma refractory to proteasome inhibitors (pis), immunomodulators (imids), and daratumumab. there will be a dose escalation phase (part 1) and dose expansion phase (part 2). in part 1 of the study, subjects will be treated at escalating dose levels. once the recommended part 2 dose (rp2d) of isb 1342 is declared in part 1, the expansion phase (part 2) will be initiated at the rp2d.

Eligibility criteria:
inclusion criteria: * documented diagnosis of multiple myeloma with measurable disease (serum, urine, or free light chain) per international myeloma working group (imwg) criteria, including non-secretory or oligo-secretory multiple myeloma which has relapsed after or is refractory to prior therapies, including proteasome inhibitors (pis), immunomodulators (imids) and anti-cd38 targeted therapies (daratumumab, isatuximab). * eastern cooperative oncology group (ecog) performance-status score of 2 or less and 1 or less (for france). * adequate hematologic, renal, and hepatic functions * seronegative for hepatitis b antigen; positive hepatitis b tests can be further evaluated by confirmatory tests, and if viral load is negative, the subject can be enrolled. * seronegative for hepatitis c antibody; if positive, then further test for the presence of antigen by hepatitis c virus polymerase chain reaction (hcv pcr). if hcv antigen tests are negative, then the subject can be enrolled. * oxygen saturation level ≥92% on room air. * left ventricular ejection fraction (lvef) ≥50% and no pericardial or pleural effusion at screening exclusion criteria: * active central nervous system involvement * exposure to daratumumab or isatuximab within 2 months prior to the start of study treatment * active plasma cell leukemia * active infectious disease * clinically significant cardiovascular and respiratory conditions * history of hiv infection * subjects requiring prohibited concomitant medications
cell therapy in limb girdle muscular dystrophy

Conditions: Limb Girdle Muscular Dystrophy

Summary: the purpose of this study was to study the effect of stem cell therapy on limb girdle muscular dystrophy patients.


Eligibility criteria:
inclusion criteria: * age group of 15 years-60 years * limb girdle muscular dystrophy diagnosed on the basis of clinical presentation * electromyographic and nerve conduction velocity findings exclusion criteria: * presence of respiratory distress * presence of acute infections such as human immunodeficient virus/hepatitis b virus/hepatitis c virus * malignancies * acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30% * pregnancy or breastfeeding

Keywords: limb girdle muscular dystrophy autologous bone marrow mononuclear cell therapy stem cell
prediction of upgrade to invasive cancer in patients diagnosed with ductal carcinoma in situ by percutaneous core needle biopsy

Conditions: Carcinoma, Ductal, Breast; Invasive Breast Cancer; IMAGE

Summary: it is considered that whether or not the accompanying invasive cancer classified through mri images of breast cancer patients identified as ductal carcinoma in situ (dcis) through preoperative tissue biopsy is significantly consistent with the postoperative stage. therefore, this study intend to evaluate the effectiveness as a diagnostic tool that can help determine the axillary lymph node surgery by predicting the possibility of post-operative up-staging using magnetic resonance imagings of breast cancer patients who have been identified as ductal carcinoma in situ and are scheduled for surgery.

1. to date, there is no significant research data on the value of the apparent diffusion coefficient (adc) that can distinguish between pure ductal carcinoma in situ (pure dcis) and invasive cancer (dcis-ic), from june 2019 to 2020 1 of the 144 patients who obtained diffusion weighted images (b=0,800,1200) with 3.0-t mri equipment and diagnosed with ductal carcinoma in situ on the biopsy, among 144 patients who did not undergo preoperative chemotherapy using a cad program, the 3-dimensional apparent diffusion coefficient value of the tumor is measured and compared with whether or not there is invasive cancer after surgery, and the optimal apparent diffusion coefficient reference value that can predict the invasive cancer will be retrospectively derived. 2. scheduled mri tests will be performed on patients enrolled from july 2020, and will be performed using the standard protocols (3t, contrast enhancement and diffuse enhancement images dwi b0,800,1200). among the mri images taken, the range of lesions is evaluated in contrast-enhanced t1-highlighted images, and the apparent diffusion coefficient values of the lesions are three-dimensionally mapped using a cad program and histogram analysis on diffused images. the adc reference value derived from the retrospective analysis is used to predict prospectively for invasive cancer in all lesions. 3. mastectomy is performed according to the existing surgical method. axillary lymph node surgery is determined according to the existing decision method (tumor location, size, range, histological grade, etc.).

Eligibility criteria:
inclusion criteria: * adult over 19 years-old * breast ductal carcinoma in-situ patients who diagnosed preoperative tissue biopsy * a person who understands this study and agrees with willingness to participate exclusion criteria: * ductal carcinoma in-situ which diagnosed excisional biopsy * when there is no lesion that can be discriminated from magnetic resonance imaging * neoadjuvant chemotherapy patients * patients who have complication (hematoma, abscess etc.) after preoperative biopsy
ecofisio, a mobile application for assessment and diagnosis using ultrasound imaging for undergraduate health science students

Conditions: Sport Injury; Educational Problems

Summary: the new called "generation z" is starting to reach college age. they have adopted technology and create a deep dependence on it, becoming more drawn to the virtual world. m-learning has experienced a huge expansion in recent years in both, medical context and medical and health's sciences education. ultrasound is an important diagnosis technique in physiotherapy, especially in sports pathology. m-learning environments could be a useful tool for improve the comprehension of ultrasound concepts and the acquisition of professional competencies. the purpose of this study was to evaluate the efficacy and the use of an interactive platform accessible through mobile devices (ecofisio) using ultrasound imaging for the development of professional competencies in the evaluation and diagnosis of sports pathologies. participants were 110 undergraduate students enrolled in two groups of this randomized controlled multicentre study: a control group (traditional learning) and experimental group (ecofisio mobile application). all participants were assessed both theoretically and by means of the objective structured clinical examination (osce) exams.


Eligibility criteria:
inclusion criteria: * to have anatomy and biomechanics previous knowledge. * to be enrolled in any required subject. * to have basic ability to use a mobile application. * to have a smartphone with internet access (android operating system). exclusion criteria: - to have received any previous training in ultrasound imaging and managing.
an evaluation of etanercept in the treatment of subjects with psoriasis

Conditions: Psoriasis

Summary: the purpose of this multicenter, open-label, prospective study is to evaluate the effectiveness and safety of etanercept in the treatment of subjects with psoriasis.


Eligibility criteria:
inclusion criteria: - stable, active plaque psoriasis involving greater than or equal to 10% of body surface area (bsa) at screening and baseline exclusion criteria: - any grade 3 or 4 adverse event or infection within 28 days before screening, or between the screening visit and study drug initiation - evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis - psoralen plus ultraviolet a radiation (puva), oral retinoids, cyclosporine, alefacept (amevive®), efalizumab (raptiva®), or any other systemic anti-psoriasis therapy within 28 days of study drug initiation - ultraviolet light b (uvb) therapy, topical steroids, topical vitamin a or d analog preparations, or anthralin within 14 days of study drug initiation (exception: topical steroids, at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable throughout trial) - prior exposure to any tumor necrosis factor (tnf)-inhibitor, including etanercept - severe comorbidities - known history of tuberculosis (tb), or previous positive purified protein derivative (ppd) test

Keywords: psoriasis
a study to evaluate the safety and immunogenicity of ev71 vaccine in pediatric subjects aged 3 to 6 years and 6 to 35 months old

Conditions: Enterovirus Infections

Summary: the objectives of this study are to evaluate the immune response and safety profiles of two injections of ev71 vaccine administrated with or without adjuvant alpo4 at 0.5-μg, 1-μg, 2-μg and 5-μg dose (if required) in children aged 3 to 6 years old and 0.25-μg (if required), 0.5-μg, 1-μg and 2-μg (if required) in 6 to 35 months old infants/toddlers.


Eligibility criteria:
inclusion criteria: 1. healthy children aged from 3 to 6 years old (i.e. ≥ 3 years old and \< 7 years old) for part a; from 6 to 35 months old (i.e. ≥ 6 months old and \< 36 months old) for part b at the time of first vaccination. 2. subject's guardians were able and willing to comply with study procedures and give written informed consent. 3. subject was able and could comply with the requirements of the protocol. 4. subject with body temperature ≤38°c. exclusion criteria: 1. subject with previous known exposure to enterovirus 71 (ev71). 2. subject with a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis associated with enterovirus infection in the past 3 months. 3. subject with gestation \< 37 weeks. 4. subject with birth weight \<2.5 kg. 5. subject with a history of hypersensitivity to vaccines, or a history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 6. family history of seizures or progressive neurological disease. 7. family history of congenital or hereditary immunodeficiency. 8. severe malnutrition or dysgenopathy. 9. major congenital defects or serious chronic illness, including perinatal brain damage. 10. subject diagnosed of having autoimmune disease (e.g., celiac disease, type i diabetes, lupus (sle), juvenile dermatomyositis, scleroderma, juvenile idiopathic arthritis (jia), immune (or idiopathic) thrombocytopenia purpura). 11. bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with im injections or blood draws. 12. any acute infections 7 days prior to administrate the first vaccination. 13. use of any investigational product (including drug, vaccine) within 30 days prior to vaccination or planned use during the study period. 14. administration of any attenuated live vaccine within 7 days prior to vaccination. 15. use of immunoglobulins or any blood products within 3 months prior to vaccination or planned use during the study period. 16. chronic administration (defined as \> 14 days) of immunosuppressants or other immunomodulators or systemic corticosteroids within 6 months prior to vaccination. 17. under anti-tuberculosis prevention or therapy. 18. any condition that in the opinion of the investigator may interfere with the evaluation of study objectives.

Keywords: vaccines hand, foot and mouth disease ev71 enteroviruses vaccine
intraperitoneal application of levobupivacaine during laparoscopic surgery in kids.

Conditions: Pain

Summary: pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (co2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal ph, and retention of the insufflated gas in the abdominal cavity after surgery. these effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics. the study hypothesis is that intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (la) instillation and la nebulization. -but these methods are not widely used in pediatrics upon our knowledge


Eligibility criteria:
inclusion criteria: 1. patient undergoing laparoscopic surgeries 2. pediatric weighing 4 kg or more 3. patients with free medical history exclusion criteria: 1. parents refusal 2. known allergy to levobupivacaine 3. acute preoperative pain other than biliary colic 4. chronic pain treatment or antiepileptic therapy 5. severe hepatic or renal impairment 6. cognitive impairment or communication problems.

Keywords: laparoscopic levobupivacaine pediatric anesthesia instillation surgeries
a clinical study that will assess how food moves through the stomach and effects blood glucose levels in subjects with schizophrenia taking sep-363856 or and prior antipsychotic (pa) standard

Conditions: Schizophrenia

Summary: a clinical study to determine whether an investigational medication (sep363856) changes how long it takes for food to move through the stomach into the small intestine in patients with schizophrenia. this study is accepting both male and female subjects. it will be conducted in approximately 6 study sites in the united states. the duration of participation will be approximtely 10 weeks.

this is a randomized, open-label, single dose two-period crossover study with two treatment sequences. for each treatment sequence, subjects will receive a single-dose of sep-363856 and prior antipsychotic (pa) standard of care (pa) in random order. up to 3 separate cohorts of subjects will be randomized to determine the final dose of sep-363856.

Eligibility criteria:
inclusion criteria: (this list is not all inclusive) * male or female subjects between 18 and 65 years of age, inclusive at time of consent. * subject meets diagnostic and statistical manual of mental disorders (dsm-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview, using the dsm-5 as a reference and confirmed using the structured clinical interview for dsm-5, clinical trials version \[scid-ct\]). * subject must have a cgi-s score ≤ 4 (normal to moderately ill) at screening * subject must have a panss total score ≤ 80 at screening and a score of ≤ 4 on the following panss items at screening: p7 (hostility) and g8 (uncooperativeness) * subjects' antipsychotic medication at screening must have had no dose change (minor dose adjustments for tolerability purposes are permitted) for at least eight weeks prior to the screening visit. exclusion criteria: (this list is not all inclusive) * subject has a dsm-5 diagnosis or presence of symptoms consistent with a dsm-5 diagnosis other than schizophrenia or intellectual disability (iq \< 70). * subject has attempted suicide within 12 months prior to screening. * subject answers "yes" to "suicidal ideation" items 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the c-ssrs at screening (ie. in the past 1 month) or at any subsequent c-ssrs assessment prior to dosing (ie, since last visit). * subject is at risk of harming him/herself or others according to the investigator's judgment.

Keywords: schizophrenia
myocardial injury and severe pneumococcal pneumonia

Conditions: Pneumonia, Pneumococcal; Myocardial Ischemia

Summary: hypothesis: the "novo" cardiovascular events (cve)in patients with severe community-acquired pneumonia (cap) are frequent (17%) and could be associated with both direct pneumococcal myocardial invasion, toxin delivery (pneumolysin) or different biomarkers (histones, nets(neutrophil extracellular traps), il (interleukin)-1b,h-fabp (heart-fatty acid bindding protein) ).the cve frequency and its impact on outcome in patients without prior heart disease (cp) has not been studied. objectives:1) to determine the incidence of myocardian injury (mi) and cve in patients with cap without cp evaluated by non-invasive techniques (echocardiograph and mri) and biomarkers levels (tn-i (troponin i), h-fabp, nt-probnp (n-terminal pro-brain natriuretic peptide) histones, nets, il 1b); 2) to assess if dma and cve are related to the etiology and their impact on outcome , 3) to investigate the presence of myocardial scarring by mri and its relationship with etiology and mi, and 4) to identify prognostic factors of dma and cve to determine level of risk.

area: intensive care unit (icu) of the participating hospitals. patients: forty patients with cap without heart disease history will be included consecutively (20 patients with pneumococcal cap and 20 patients with non-pneumococcal cap).ten healthy volunteers (controls) are included. variables: epidemiological, clinical and hemodynamic variables are recorded. presence of mi and cve measured by echocardiography and by biomarkers will be evaluated during the icu stay. presence of scarring miocardic by mri technique will be determined at month 6 since icu admission. statistical analysis: categorical (fisher's exact test) and continuous variables( wilconxon and anova) will be used to determine differences between them. the pearson correlation, roc (discriminatory power) and logistic regression analysis(independent association) will be used to determine the association between variables and outcome. a p-value of 0.05 will be considered significant.

Eligibility criteria:
inclusion criteria: 1. - patients admitted to the icu due to community-acquired pneumonia according to idsa/ats criteria 2. - no history of heart diasese 3. - informed consent signed exclusion criteria: 1. - hospital or ventilator-associated pneumonia 2. - health care-associated pneumonia 3. - viral pneumonia 4. - bacterial/viral coinfection pneumonia 5. - history of heart disease 6. - chronic administration of statins 7. - chronic administration of steorids (prednisolone more 20 mg/day or equivalent) 8. - no signed informed consent

Keywords: pneumococcal pneumonia acute cardiovascular events
efficacy of sildenafil on the morbi-mortality of peripheral arterial diseased patients with intermittent claudication

Conditions: Peripheral Arterial Occlusive Disease

Summary: peripheral arterial disease (pad) is a highly debilitating disease that affects 202 million people around the world and about 7 million people in france. morbi-mortality from cardiovascular events is increased in this population. intermittent claudication is the most common clinical feature of pad. primary therapeutic approach is medical treatment and advice to walk. sildenafil, a pdei type 5, is well tolerated, largely used in impotence and has interesting clinical delay and duration of action in the concept of a potential use in claudication. for patients agreeing and signing informed consent, randomisation of treatment (placebo/sildenafil) will be done. treatment will be proposed in addition to usual treatment. the experimental drug will be delivered for a 1 month treatment. first follow up visit at month one will focus on tolerance, compliance and eventual side effects. if no major side effect is found the study drug will then be delivered for an additional 2 months. patients will be evaluated at month 3 (second follow-up visit) for persistent or non-persistent indication for revascularisation and addressed for revascularization if needed. in parallel focus on tolerance, compliance and eventual side effects will be done. if no major side effect is found, the study drug will be delivered for an additional 3 months treatment. third and fourth follow-up visit are scheduled at month 6 (end of treatment) and month 9 (3 months after the end of experimental drugs).


Eligibility criteria:
inclusion criteria: * grade i cat 2 or 3 claudication despite optimal medical treatment * reporting a vascular claudication history for at least 3 months * able to achieve a walking treadmill test, walking time on treadmill (3.2km/h, 10% slope) less than 5 minutes * having no cons sildenafil indication * must be on optimal medical therapy (ace inhibitors / at2 antagonist + antiplatelet + lipid lowering drugs) for at least 1 month exclusion criteria: * critical ischemia * previous history of myocardial infarction or angina not stabilized * amblyopia * treated with nitrates (nitroglycerin ...) or drugs interfering with the action of the sildenafil * pregnant woman and woman in labor * major person subject to reinforced protection, deprived of their liberty by judicial or administrative decision, hospitalized without consent or admitted to a health or social establishment for purposes other than research * being in an exclusion period for another biomedical study
spinal cord stimulation (scs) dosing study

Conditions: Back Pain; Leg Pain

Summary: this study characterized the effects of amplitude on subject satisfaction and pain relief in subjects being treated by scs.

this feasibility study assessed the following outcomes: * patient satisfaction * vas pain scores

Eligibility criteria:
inclusion criteria: 1. 22 years of age or older 2. implanted with a restoresensor system (for back and leg pain) for at least 1 month 3. has approproate scs settings 4. willing and able to provide signed and dated informed consent 5. capable of comprehending and consenting in english 6. capable of getting into the supine and sitting positions 7. willing and able to comply with all study procedures and visits 8. on stable (no change in dose, route, or frequency) prescribed pain medications exclusion criteria: 1. implanted with leads for peripheral nerve stimulation or an implantable intrathecal drug delivery system 2. had a pain-related surgery in the previous 1 month of enrollment or the intent to undergo surgery during the period of the study 3. implanted with quadripolar lead 4. currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study 5. pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study 6. has untreated major psychiatric comorbidity 7. has serious drug-related behavioral issues 8. has unresolved major issues of secondary gain