Kornimate/medical-research-clean huggingface dataset:
lenalidomide and dexamethasone in primary plasma cell leukemia

Conditions: Primary Plasma Cell Leukemia

Summary: this is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (ld) as first line therapy in previously untreated patients with primary plasma cell leukemia (ppcl).

the primary endpoint was response rate according to international uniform criteria; secondary endpoints were: i) time to progression (ttp), progression free survival (pfs, and overall survival (os); ii) percentage of eligible ppcl patients able to mobilize and collect peripheral blood stem cells after ld treatment; iii) percentage of eligible ppcl patients able to undergo autologous or allogeneic stem cells transplantation after ld treatment; iv) serious/severe adverse event (saes) rate.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients fulfilling the imwg diagnostic criteria of ppcl * age \> 18 years * ecog performance status of 0,1 or 2 * life expectancy of at least 12 weeks exclusion criteria: * myocardial infarction within 6 months prior to enrollment or uncontrolled angina * severe uncontrolled ventricular arrhythmias * ecg evidence of acute ischemia or active conduction system abnormalities * female subjects either pregnant or breast-feeding * serious medical or psychiatric illness * total bilirubin greater than 2.0 mg/dl and/or sgot or sgpt greater than two and a half times normal (unless due to primary malignancy) * history of severe hepatic dysfunction * active infections or hiv positivity * uncontrolled insulin-dependent diabetes mellitus * uncompensated major thyroid or adrenal dysfunction * hemodialysis or peritoneal dialysis * renal dysfunction (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator) * ecog performance status of 3 (unless due to primary malignancy; in this case, enrollment at the discretion of the principal investigator)

Keywords: plasma cell leukemia lenalidomide dexamethasone multiple myeloma bortezomib stem cell transplantation
diagnosis, treatment status and prognosis of cholangiocarcinoma in china: a multicenter, two-way, non-intervention study

Conditions: Cholangiocarcinoma

Summary: this is a multicenter, two-way, non-intervention study. the main purpose: understand the current status of diagnosis and treatment of cholangiocarcinoma patients in china and observe the effect of different treatment options on patient recurrence and long-term survival secondary purpose: 1. exploring the actual clinical treatment situation and its compliance with the existing diagnosis and treatment of bile duct cancer 2. exploring the establishment of clinical research standard fields and standards for diagnosis and treatment of bile duct cancer


Eligibility criteria:
inclusion criteria: 1. above the age of 18 years old, male or female 2. clinical diagnosis of patients with cholangiocarcinoma 3. child-pugh classification of a, b 4. eastern cooperative oncology group scoring system (ecog) score of 0-2 points exclusion criteria: * none
the effect of reading therapy on newborns

Conditions: Autonomic Nervous System Diseases

Summary: the primary purpose of this pilot study is to specifically examine the effect of parental reading on the ans of mother and neonate in the hospital setting. the investigators will examine the effect of live maternal-infant reading on typically developing infants to better understand the physiological benefits of live reading on newborns.

supporting infant ans development has been implicated in their improved cardiorespiratory and neuropsychiatric outcome; furthermore, improved parasympathetic activity, a branch of ans, is a predictor of the mother-infant relationship, and the best marker for caregiving behavior. in feldman and eidelman's 2003 study, they demonstrated that mother-infant skin-to-skin contact, also known as kangaroo care, accelerates ans maturation in pre-term infants, which is critical for their recovery. if reading is shown to have a positive effect on mother infant ans, hospitals will be able to incorporate this into practice as a feasible alternative for when kangaroo care isn't possible. the investigators hope to learn if these reading interventions will help to mitigate distress symptoms, among both mother and baby, within the hospital. the investigators will examine the association of reading therapy with the infant's crying patterns, length of stay in the hospital, weight gain, and behavior compared to before the reading was done. seeing that scala's findings from 2018 is the only indication of physiologic benefits of reading to infants in the hospital, additional research is required in this particular area. the testing and application of reading therapy in the neonatal intensive care unit (nicu) would improve a high-stress environment for both parents and infants. data collected from this project will not only add some much-needed information to the limited knowledge of the physiological effects of reading on neonates, but also demonstrate how infant outcomes can be improved in a cost-effective, efficient manner within the hospital setting.

Eligibility criteria:
inclusion criteria: * admitted to the tulane-lakeside hospital newborn nursery * corrected gestational age 34 weeks or older * no identified hearing disorder * do not have a diagnosed developmental disability (i.e. down syndrome) * do not have fetal alcohol syndrome * medically cleared to participate in the study * biological mother able/willing to give consent in english \& complete surveys. exclusion criteria: * corrected gestational age \< 34 weeks old * has an identified or potential hearing disorder (i.e, failed hearing screen) * has diagnosed developmental disability (i.e. down syndrome) * has fetal alcohol syndrome * is not medically cleared to participate in the study * biological mother unable/unwilling to give consent.

Keywords: reading neonates new borns autonomic nervous system
a study to evaluate the efficacy, safety, and immunogenicity of mrna-1647 cytomegalovirus (cmv) vaccine in allogenic hematopoietic cell transplantation (hct) participants.

Conditions: Cytomegalovirus Infection

Summary: the main purpose of the study is to evaluate the efficacy and safety of mrna-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (cs-cmvi) in the period following cessation of cmv prophylactic treatment (for example, letermovir) on day 100 post-hct through month 9 post-hct.


Eligibility criteria:
inclusion criteria: * receipt of an allogeneic hct. * cmv-seropositive, defined as a documented positive test for anti-cmv igg. * high-risk for cmv: hct from related, unrelated, or haploidentical donor with post-transplant cyclophosphamide for graft-versus-host-disease (gvhd) prophylaxis; or hct from related or unrelated donor with at least one mismatch at any of the following human leukocyte antigen (hla) gene loci (hla-a, b, c, and drb1); or hct from related or unrelated donor with myeloablative conditioning. * persons of nonchildbearing potential or of childbearing potential with negative urine or serum pregnancy test on the day of first study injection. * persons of childbearing potential who have practiced adequate contraception or have abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose. * persons of childbearing potential who have agreed to continue adequate contraception or abstain from all activities that could result in pregnancy through 3 months after last study injection. * persons who are not currently breast/chestfeeding. * willingness to comply with study procedures and provide written informed consent. exclusion criteria: * history of a diagnosis or condition that, in the judgment of the investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. * a documented positive human immunodeficiency virus (hiv) test. * treatment with alemtuzumab (campath®), antithymocyte globulin (atg), or any equivalent in-vivo t cell depleting agent within 12 months. * hct with ex-vivo t cell depletion. * low risk for cmv: hct from related or unrelated donor with reduced intensity conditioning (ric) and no other high-risk features. * history of prior hematopoietic cell transplantation within 12 months. * receipt of prior investigational cmv vaccines or participation in another cmv therapeutic study that may interfere with study outcome measures as determined by the investigator. * suspected or known allergic reaction to any component of any mrna vaccine or its excipients.

Keywords: human cytomegalovirus human herpesvirus mrna-1647 moderna cmv cytomegalovirus vaccine cytomegalovirus infections cytomegalovirus congenital virus disease infection viral dna virus infections messenger rna hematopoietic cell transplantation
a study of chemoradiotherapy with shr-1316 for treatment of locally advanced cervical cancer

Conditions: Locally Advanced Cervical Cancer

Summary: the primary purpose of this study is to evaluate the safety of shr-1316 plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. the second purpose of this study is to evaluate the efficacy and pk traits; the exploratory study is to explore the biomarker 、immunogenicity and so on .


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix； 3. has locally advanced cervical cancer； 4. at least one measurable lesion ( recist version 1.1)； 5. investigator assess it is suitable for concurrent chemoradiotherapy; 6. has provided a tissue sample from tumor lesion; 7. cooperative oncology group (ecog) performance status of 0 or 1; 8. bmi≥18.5kg/m2； 9. female participants of childbearing potential must agree to use highly effective contraception during the treatment period and for at least 7 months after the last dose of drug，female participants' hcg must be negative within 3 days prior to enrollment and must be non-lactating. exclusion criteria: 1. histopathologically confirmed small cell carcinoma (neuroendocrine) or mucinous adenocarcinoma of the cervix； 2. the presence of distant metastatic disease was confirmed by pathology or imaging; 3. has previously undergone hysterectomy (including subtotal hysterectomy) or plan to undergo hysterectomy for cervical cancer, or plan to adopt fertility preservation therapy; 4. in the investigator's judgment, there is a disease (such as severe diabetes, neurological or psychiatric illness, etc.) or any other condition that seriously endangers the subject's safety, confuses the study results, or interferes with the subject's ability to complete the study.
practice of ventilation in patients with ards due to covid-19 vs pneumonia

Conditions: Acute Respiratory Distress Syndrome; COVID-19; Pneumonia; Mechanical Ventilation Complication

Summary: this study aims to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with covid-19 ards and ards from another pulmonary infection. the investigators will use individual patient data from four recently published large observational covid-9 studies, including the 'practice of ventilation in covid-19 patients' (provent-covid) study, the 'epidemiology of covid-19 patients in the icu' (epiccov) study, the 'sati-covid-19 - clinical characteristics and outcomes of patients with covid-19 on mechanical ventilation in argentina: a prospective, multicenter cohort study' and the ciberesucicovid - personalized risk and prognosis factors and follow-up at one year of the patients hospitalized in the spanish intensive care units infected with covid -19' study. the investigators will use the individual patient data from ards patients with another pulmonary infection from the 'lung -safe - large observational study to understand the global impact of severe acute respiratory failure' study and the 'ericc - epidemiology of respiratory insufficiency in critical care' study.

early on in the pandemic, it was frequently proposed that ards caused by covid-19 and ards caused by another cause were distinct in a number of ways. covid-19 related ards phenotypes have been suggested, based on differences in respiratory system compliance (crs) and the severity of the hypoxemia. other reports have even suggested that lung-protective ventilation strategies for patients with ards caused by covid-19 should differ from those used before the pandemic. the use of low tidal volumes (vt) and prone positioning, which have been shown to be useful in reducing death in patients with ards prior to the pandemic, were also shown to be effective in patients with covid-19 related ards, according to several reports. in the discussion of how to ventilate patients with covid-19 related ards, the disagreement over other ventilatory settings, such as the best positive end-expiratory pressure (peep) and the use of recruitment manoeuvres, remains remarkably lively. to compare epidemiology, management of invasive ventilation and outcomes in critically ill patients with covid-19 ards and ards from another pulmonary infection, the investigators will use individual patient data from provent-covid, epiccov, sati-covid-19, ciberesucicovid, lung-safe and ericc.

Eligibility criteria:
inclusion criteria: 1. cause for ards is covid -19 (confirmed with polymerase chain reaction (pcr) and/or presence of typical abnormalities on chest computer tomography (ct) and/or x-ray) or a pulmonary infection from another origen 2. meeting a berlin criteria for ards 3. invasive ventilation exclusion criteria: 1. age \< 18 years 2. any form of non-invasive ventilation

Keywords: mechanical ventilation acute respiratory distress syndrome ventilation practice pulmonary infection covid-19
study of single agent pembrolizumab (mk-3475) versus single agent chemotherapy for metastatic triple negative breast cancer (mk-3475-119/keynote-119)

Conditions: Metastatic Triple Negative Breast Cancer

Summary: in this study, participants with metastatic triple negative breast cancer (mtnbc) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (treatment of physician's choice, tpc) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine. the primary study hypothesis is that pembrolizumab extends overall survival compared to tpc.


Eligibility criteria:
inclusion criteria: * centrally confirmed stage iv/m1 mtnbc * newly obtained tumor biopsy from metastatic site * central determination of programmed cell death ligand 1 (pd-l1) tumor status * received either one or two prior systemic treatments for metastatic breast cancer and have documented disease progression on or after the most recent therapy * previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or metastatic setting * eastern cooperative oncology group (ecog) performance status of 0 or 1 within 10 days prior to study start * adequate organ function exclusion criteria: * participation in another clinical trial within 4 weeks * monoclonal antibody (mab) for direct anti-neoplastic treatment within 4 weeks * chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2 weeks * active autoimmune disease that required systemic treatment in the past 2 years * diagnosed with immunodeficiency or receiving systemic steroid therapy or another form of immunosuppressive therapy within 7 days * known additional malignancy that required treatment or progressed in last 5 years * known active brain metastases and/or carcinomatous meningitis * prior therapy with an anti-programmed cell death (pd)-1, anti-pd-ligand-1 (anti-pd-l1), anti-pd-l2 agent or with an agent directed to another co-inhibitory t-cell receptor (e.g. cytotoxic t-lymphocyte associated protein 4 \[ctla-4\], ox-40, cd137) or previously participated in any pembrolizumab (mk-3475) clinical studies

Keywords: programmed cell death-1 (pd1, pd-1) programmed death-ligand 1 (pdl1, pd-l1)
hemodynamic management in autologous blood collection for cabg surgery

Conditions: Coronary Artery Bypass Grafting; Acute Normovolemic Hemodilution

Summary: in this study, investigated the hemodynamic differences between patients who underwent acute normovolemic hemodilution during the autologous blood collection procedure in coronary artery bypass graft surgery and those who did not, using hemodynamic and cardiac data obtained by mostcare's pressure recording analytical method (pram).

coronary artery bypass graft (cabg) surgeries are surgeries in which the need for blood transfusion is high. allogeneic transfusion and transfusion-related complications have led researchers to use different techniques. autologous blood collection method is one of the alternative methods used to eliminate the need for transfusion. the acute normovolemic hemodilution technique traditionally applied during autologous blood collection causes hemodilution in cabg surgeries and increases the risk of bleeding in patients. in this study, vasopressor infusion technique was used as an alternative technique to avoid hemodilution during autologous blood collection. these two techniques (acute normovolemic hemodilution - vasopressor infusion) applied to maintain hemodynamic stabilization during autologous blood collection were compared with the advanced cardiac and hemodynamic data provided by the pressure recording analytical method. the primary aim of the study was to compare cardiac cycle efficiency (cce), which is a cardiac performance parameter and provides estimates of the energy spent by the cardiovascular system to maintain hemodynamic balance. secondary objectives are to compare other advanced hemodynamic and postoperative laboratory parameters.

Eligibility criteria:
inclusion criteria: * age at least 18 years * undergoing isolated coronary artery bypass grafting surgery under general anesthesia * invasive blood pressure (radial or femoral) and mostcare monitoring * recruitment after booking for surgery with sufficient time to read, understand and question study patient information prior to attending for surgery * ability and willingness to provide informed consent exclusion criteria: * refuse to consent to the study * arterial wave form distortion * cardiac arrhythmia * inappropriate identification of the dicrotic notch for any reason * hemodynamic instability defined as mean arterial blood pressure \< 65 mmhg * preoperative requirement of inotrope/vasopressor infusion * preoperatively receiving vasoactive drugs * patients fitted with an intra-aortic balloon pump * patients fitted with extracorporeal membrane oxygenation * critically ill patients requiring preoperative intensive care unit * presence of intraabdominal hypertension * new york heart association class 3-4 heart failure * congestive heart failure with ejection fraction \< 35% * glomerular filtration rate \< 30 ml/min/1.73 m2 * ongoing renal replacement therapy
botulinum toxin (botox) for cerebral palsy

Conditions: Cerebral Palsy; Muscle Spasticity

Summary: this study examines botulinum toxin (botox, or btx) for the treatment of muscle twitches and spasticity associated with cerebral palsy in children. botulinum toxin is a naturally occurring bacterial toxin (botulinum toxin) that inactivates certain parts of muscles.

this trial will test the effectiveness of btx injections versus placebo to reduce plantar-flexor spasticity and improve function and mobility in children with spastic diplegia, a common form of cerebral palsy. the study will evaluate the effects of the treatment across five domains that relate to disability: pathophysiology, impairment, functional limitation, disability, and societal limitation. forty children, ages 4 to 12 years, will be recruited and randomized into one of two groups. group a will receive btx. group b will receive a placebo injection. participants will be assessed at the beginning of the trial and at weeks 3, 8, 12, and 24. assessments include quantitative electromyographic kinesiology measurements, electromechanical measurement of joint torque across the ankle joint using the spasticity measurement system, gross motor function measure, physical exam parameters, energy expenditure using the energy cost index, kinematic gait analysis, and the canadian occupational performance measure. participants are followed for a total of 6 months. participants initially randomized to group b will have the opportunity for btx treatment after 24 weeks.

Eligibility criteria:
inclusion criteria: * spastic diplegic cerebral palsy * community or independent ambulators * expressive communication skills at age 3 or above * stable social environment * reasonable proximity to the medical center * physical therapy at least once per week * no other serious health problems that would interfere with the study exclusion criteria: * other forms of cerebral palsy * previous treatment with botulinum toxin * musculoskeletal contractures greater than 15 degrees * unstable social environment

Keywords: cerebral palsy spasticity botulinum toxin botox
a study of jnj-88549968 for the treatment of calreticulin (calr)-mutated myeloproliferative neoplasms

Conditions: Myeloproliferative Disorders; Essential Thrombocythemia; Neoplasms; Myelofibrosis

Summary: the purpose of this study is to characterize safety and to determine the recommended phase 2 dose (rp2d\[s\]) and optimal dosing schedule(s) of jnj-88549968, in part 1 (dose escalation); to characterize the safety of jnj- 88549968 at rp2d(s), in part 2 (cohort expansion).


Eligibility criteria:
inclusion criteria: * be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent * positive for a calreticulin (calr) driver mutation of essential thrombocythemia (et) or myelofibrosis (mf) * participants with et and mf with risk characteristics as described in the protocol * have an eastern cooperative oncology group (ecog) performance status grade of less than or equal to (\<=) 2 exclusion criteria: * known allergies, hypersensitivity, or intolerance to the excipients of the study treatment * concurrent or recently diagnosed or treated malignancies present at the time of participant screening. exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. participants cured of another malignant disease with no sign of relapse greater than or equal to (\>=) 3 years after treatment ended are allowed to enter the study * prior solid organ transplantation * either of the following regarding hematopoietic stem cell transplantation: 1. prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of jnj-88549968 or 2. evidence of graft versus host disease (gvhd) that requires immunosuppressant therapy * history of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment
study evaluating the use of etanercept in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * diagnosis of ankylosing spondylitis (as) exclusion criteria: * hypersensitivity to etanercept * active infection including chronic or localised infection * sepsis or risk of sepsis