Kornimate/medical-research-clean huggingface dataset:
a study of daratumumab in japanese participants with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the tolerability and safety of daratumumab in japanese participants with relapsed (the return of a medical problem) or refractory (not responding to treatment) multiple myeloma (cancer of plasma cells in bone marrow, characterized by the presence of abnormal proteins in the blood).

this is a phase 1, open-label (all participants and study personnel will know the identity of the study treatments) and multicenter (study conducted at multiple sites) study in japanese participants. the study will include a screening phase, a treatment phase, and a follow-up phase. the treatment phase consists of 2 parts: intense dosing regimen and less intense dosing regimen. follow-up phase will be until 8 weeks after last dose administration/death/lost to follow up/consent withdrawal for study participation or study end, whichever occurs first. the primary endpoints will be dose limiting toxicity (dlts) and overall adverse events (aes) profiling. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants proven to have symptomatic (having symptoms) multiple myeloma according the international myeloma working group (imwg) diagnostic criteria * participant must have measurable disease defined by either or both the following measurements: a) serum m-protein greater than or equal to (\>=) 1 gram per deciliter (g/dl) (\>=10 gram per liter \[g/l\]) (except for serum immunoglobulin a \[iga\] m-protein \>= 0.5 g/dl); b) urine m-protein \>=200 milligram per 24 hour (mg/24 h); in case immunoglobulin d \[igd\] or immunoglobulin e \[ige\] m-protein, quantification should be performed * participant must have relapsed or refractory multiple myeloma after receiving at least 2 previous therapies, and without further established treatment options * participant must have an eastern cooperative oncology group (ecog) performance status score of 0, 1, or 2 * participant must have life expectancy greater than (\>) 3 months exclusion criteria: * participant has received daratumumab or other anti-cluster of differentiation 38 (anti-cd38) therapies previously * participant has received anti-myeloma treatment within 2 weeks before administration of the study drug * participant has previously received an allogenic stem cell transplant; or participant has received autologous stem cell transplantation (asct) within 12 weeks before administration of the study drug * participant has a history of malignancy (other than multiple myeloma) within 5 years before administration of the study drug * participant is exhibiting clinical signs of meningeal involvement of multiple myeloma

Keywords: multiple myeloma daratumumab jnj-54767414 phase 1 relapse refractory
pulmonary rehabilitation in asthmatic patient

Conditions: Asthmatic; Children

Summary: asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. the pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.

the asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance. thus, the treatment of these individuals should be extended to pulmonary rehabilitation. randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents. in a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial. the control of the disease has not been evaluated by specific questionnaires in any study. the assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training. in addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results. all these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.

Eligibility criteria:
inclusion criteria: * between six and 18 years old * asthma-diagnosed patients * under medical treatment and disease control exclusion criteria: * fail to carry out the protocol evaluations * interrupt the medical care and/or drug-based treatment * acute lung infection or other chronic lung diseases * other comorbidities (neuropathies, heart disease) * missing in more than 20% the rehabilitation protocol

Keywords: pulmonary rehabilitation asthma children teenager physical capacity
treatment of initial clostridium difficile infection

Conditions: Clostridium Difficile Infection

Summary: investigators designed an open, two-arm study to compare oral vancomycin with a fecal microbiota transplant (fmt) from a fecal donor-unrelated donor mix (furm) as treatments for the first clostridium difficile infection (cdi) episode among hospitalized patients.

investigators designed an open, two-arm study to compare oral vancomycin with an fmt-furm as treatments for the first clostridium difficile infection (cdi) episode among hospitalized patients. from each patient, a fecal sample was obtained at days 0, 3, and 7 after treatment. specimens are cultured to isolate c. difficile, and c. difficile are assessed for the presence of genes encoding enterotoxin (tcdb), cytotoxin (tcda), the binary toxin a (cdta), binary toxin b (cdtb), and deletions within the negative regulator of toxin a and b production (tcdc) by polymerase chain reaction (pcr). the minimum inhibitory concentrations (mics) of ciprofloxacin, moxifloxacin, erythromycin, clindamycin, vancomycin, metronidazole, linezolid, fidaxomicin, and tetracycline against c. difficile are measured using the agar dilution method. fecal samples and fmt-furm are analyzed by 16 subunit ribosomal ribonucleic acid (16s rrna) metagenomic sequencing.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cdi (first episode) * older than 18 years old exclusion criteria: * patients younger than 18 years old
studying infant nutrition and blood sugar

Conditions: Insulin Resistance; Obesity

Summary: the purpose of this study is to learn about how breast milk from mothers with insulin-resistance may be different. investigators are specifically studying insulin concentrations in breast milk. investigators are also studying how insulin in breast milk might affect a baby's intestines and pancreas.


Eligibility criteria:
inclusion criteria: * mothers ≥ 19 years of age * mothers intending to exclusively breastfeed for at least 5months * mothers comfortable with feeding their infants expressed breast milk from a bottle at 2-weeks postpartum * trial of labor (no scheduled c-sections) * singleton birth * healthy infants * "normal weight" will be defined as pre-pregnant bmi between 18.5-23.9 kg/m2 and passing the 28 week oral glucose tolerance test. * "insulin resistance" will be defined as meeting any of the following: * pre-pregnant bmi ≥ 28 and failed the 28 week oral glucose screening test * pre-pregnant bmi ≥ 28 and diagnosis of either a1 ("diet controlled") or a2 ("insulin-requiring") gestational diabetes during pregnancy, but insulin therapy discontinued after birth. * pre-pregnant bmi ≥ 28 and diagnosed with type 2 diabetes during pregnancy * pre-pregnant bmi ≥ 30, and unmediated. exclusion criteria: * scheduled c-sections or emergency c-sections with no labor (natural or induced) * maternal insulin therapy after birth * significant maternal health concern including type 1 diabetes, renal, kidney, thyroid, or cardiovascular disease, pre-eclampsia, or other disease. * delivery before 37 weeks * infant birth weight \<2500g * infant medical or genetic indications that would impact normal feeding behavior, insulin signaling or growth patterns * infant supplementation with infant formula (glucose gel or donor milk is acceptable)
safety and tolerability of low motoneuron stimulation via transcranial magnetic stimulation in spinal muscular atrophy

Conditions: Spinal Muscular Atrophy (SMA)

Summary: there is a general physiological rule that any organ or system needs some minimal amount of activity to prevent its atrophy or degeneration. although the relevance of that rule to exercises in neuromuscular patients and for sma in particular is not definitely proven, clinical observations seem to support this assumption. also there are several experimental studies which provide additional support for utility of exercise for sma. however, making regular exercises may be very challenging with sma not only due to physical limitations, but due to psychological either. while being considered as safe and well tolerated intervention, tms is able to mimic effects of real physical exercises, at least at the level of low motoneuron, it also provides several advantages. for example, possibility to exercise non-collaborative infants, minimization of psychological motivation impact in adults and/or ability to involve very weak muscle groups.


Eligibility criteria:
inclusion criteria: * subject has a diagnosis of 5q-autosomal recessive sma confirmed by dna test. * informed consent. * a minimum score of 1 for entry item "a" of the revised upper limb module (rulm) scale for sma: "can use hands to hold pencil or pick up a coin/token or drive a powered chair, use phone key pad" exclusion criteria: * subject has severe joint contractures that would affect ability to perform study measures, determined by the study physician. * subject has a deconditioned respiratory system, per the discretion of the physician investigator. * subject has behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator.

Keywords: spinal muscular atrophy survival motor neuron protein (smn) neurofilament (nf) transcranial magnetic stimulation (tms)
to observe the impacts of anti-tumor necrosis factor (tnf) effectiveness on improvement in work place and household productivity for patients with psoriatic arthritis (psa)

Conditions: Psoriatic Arthritis; Work Productivity

Summary: this post marketing observational study is designed to provide the initial data on work impairment of psa patients in turkey, as well as changes in work impairment, life quality and clinical response during treatment with anti-tnf agents.


Eligibility criteria:
inclusion criteria: * actively working, either full-time or part-time * previous confirmed diagnosis of psa by a rheumatologist * patients for whom the physician has initiated psa treatment with an anti-tnf in accordance with turkish ministry of health regulations and reimbursement criteria * able to provide authorization to use and disclose their health related information exclusion criteria: * patients with a history of an allergic reaction or significant sensitivity to anti-tnf agents * patients with possible follow-up problems during the planned study period or patients who may not be compliant to treatment as evaluated by the investigator/treating physician * patients participating in any clinical trial of an experimental drug 30 days prior to the baseline visit

Keywords: work productivity anti-tnfs psoriatic arthritis
cvd risk factors and sexual identity in women

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to examine potential differences in the prevalence and pattern of risk factors for coronary heart disease in a sample of 500 self-identified lesbians and 500 heterosexual women, matched for age, socioeconomic status, and ethnicity.

background: coronary heart disease (chd) is the leading cause of mortality among women living in the united states, regardless of race and ethnicity and is likely the leading cause of mortality among lesbians. however, in various reports since 1994, the national institute of mental health, the centers for disease control and prevention, the american medical association, the american public health association, and the institute of medicine (iom) have pointed out that health care and health research affecting lesbian women are inadequate. as women, lesbians share many of the same health concerns of all women. however, as emphasized in the iom report on lesbian health "factors assumed to place women at risk for or to protect them against health disorders may not be present at the same levels or operate in the same way for lesbians". the iom report also recognizes that "women who self-identify as lesbian may also experience stressors not commonly faced by heterosexual women" and that "it is important to understand the factors that are unique to lesbians and their impact on lesbians' health". data which do exist from household surveys and studies utilizing convenience samples indicate that women who identify as lesbian may differ from heterosexual women in several important factors which contribute to the development of chd. however, to date there has not been a comprehensive examination of chd risk in a large sample of women who identify as lesbian or an examination of how their pattern of risk factors or overall risk for chd may differ from a sample of demographically similar heterosexual women. design narrative: the study is a case-control, cross-sectional survey that includes both behavior (alcohol, smoking, substance use, physical activity) and physiological (lipids, blood pressure, adiposity) measures. self-identified lesbian women will be age, education, and racially matched to heterosexual women. the study will test the hypotheses that the prevalence and pattern of coronary heart disease (chd) risk factors are different between lesbians and heterosexual women. the study will also determine the absolute and relative risk estimates for chd based on the framingham multiple-risk-factor assessment equations, and test the hypothesis that lesbians are at increased risk of chd compared to heterosexual women.

Eligibility criteria:
over 35 years old no cvd
pdiuc protocol for placental accreta

Conditions: Placenta Accreta

Summary: the aim of this study is to evaluate a novel protocol to conserve the uterus during cesarean delivery indicated for placenta accreta.

placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. the incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of cesarean delivery. placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. however, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.

Eligibility criteria:
inclusion criteria: * women with diagnosis of placenta accreta (us or mri based diagnosis) * women who decline hysterectomy * pregnancy at 28 weeks of gestation or beyond * women who accept to participate in the study exclusion criteria: * emergency cesarean delivery (women with active bleeding) * women with cardiac diseases * women with coagulopathy
exploration of cluster headache in a pet-mri study

Conditions: Cluster Headache, Episodic

Summary: observational study in pet-mri using the 5-ht1a agonist pet radiotracer \[18f\]f13640.


Eligibility criteria:
inclusion criteria: * male * age between 20 to 45 years old * weight between 50 to 90 kg * no psychiatric or neurologic pathological history * no cranial trauma history with loss of consciousness * no juridical protection * free and informed consent * affiliated with a social security scheme or similar exclusion criteria: * subject with present or past dependence on alcohol or any other addictive substance according to the dsm-iv-tr criteria, with the exception of nicotine, caffeine and cannabis * subject already participating in another biomedical research project or having participated for less than a year in a study using ionizing radiation * subject with a contraindication to mri exams * subject with a contraindication to pet scans using \[18f\] f13640: hypersensitivity to the active substance or to one of the excipients (sodium chloride) * subject with a contraindication to sumatriptan * patients with an active infectious disease or associated serious and progressive medical pathology * subjects with an inability to understand or carry out the study (language barrier, obvious lack of motivation, etc...) as judged by the investigator * patient having exceeded the annual amount of compensation authorized for participation in research protocols.

Keywords: cluster headache pet-mri 5ht1a
cirrhosis medical home

Conditions: Cirrhosis, Liver

Summary: to address the health care system's lack of care coordination, the institute of medicine and centers for medicare and medicaid services recommend the development of collaborative care models (ccm) in a wide range of clinical settings. ccms are intended to provide coordinated, personalized care pragmatically using care coordinators. ccms have successfully improved care in multiple patient populations, ranging from frail older adults to depression. in contrast, for patients with cirrhosis, there is a paucity of data to support the benefit of ccm in this medically complex and vulnerable population. at indiana university, researchers have over 20 years of experience in developing, testing, and implementing ccms successfully for patients living with dementia or depression. building on these successes, we have customized the ccm to best meet the unique and complex biopsychosocial needs of patients with cirrhosis: the cirrhosis medical home.

in the cirrhosis medical home, a care coordinator, supported by an interdisciplinary clinical team, will deliver a personalized intervention guided by a set of innovative tools: (i) patient-centered care protocols, (ii) a mobile office, (iii) care coordination support software, and (iv) dynamic feedback measures. the overall goal is to improve quality of life of patients discharged from the hospital with cirrhosis and to reduce acute health care utilization for patients with cirrhosis. additionally, up to 40 caregivers will be enrolled in the trial.

Eligibility criteria:
inclusion criteria for patients: * age ≥18 years * cirrhosis based on: * biopsy * characteristic clinical, laboratory, and imaging findings * decompensated cirrhosis as denoted by either: * active ascites requiring paracentesis during hospitalization or * active overt hepatic encephalopathy requiring lactulose during hospitalization * poor quality of life as defined by: * sf-36 physical and/or mental component summary scale \<40 (1sd below the mean of healthy subjects) * discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care * able to be consented, either in person or through legally authorized representative * access to a telephone inclusion criteria for caregivers: * age ≥18 years * identified caregiver of patient * able to be consented, either in person or through legally authorized representative * access to a telephone exclusion criteria for patients: * solid organ transplant of any organ * life expectancy of less than 6 months * anticipated liver transplant within 6 months * history of dementing illnesses and other neurodegenerative diseases such as alzheimer's disease, parkinson's disease, or vascular dementia * unable to complete study questionnaire due to hearing loss * legally blind * pregnant or nursing * incarcerated * concurrent enrollment in a related interventional research study exclusion criteria for caregivers: * impaired cognitive function * unable to complete study questionnaire due to hearing loss * legally blind * incarcerated
evaluation of crispr-based test for the rapid identification of tb in pulmonary tuberculosis suspects

Conditions: Tuberculosis, Pulmonary

Summary: this observational mycobacterium tuberculosis (mtb) diagnostics evaluation study is a prospective study of pulmonary tb suspects who are undergoing sputum or bronchoalveolar lavage fluid (balf) evaluation for pulmonary tb. the sensitivity and specificity of the crispr-based assay will be compared to clinical diagnosis, conventional culture methods and xpert mtb/rif assay on same batch specimens.


Eligibility criteria:
inclusion criteria: * suspected pulmonary tb. * ability and willingness of candidate or legal guardian/representative to provide informed consent. * men and women age equal to or greater than 18 years. exclusion criteria: * either receipt of ≥48 cumulative hours or three or more doses of anti-tb treatment within 180 days prior to completion of second sputum collection for xpert testing